Category: Press Releases

• Parallel programs will advance MIIST305 in ulcerative colitis (UC) and gastrointestinal acute radiation syndrome (GI-ARS)
• Phase 1 clinical studies expected to begin in 2025

CLAREMONT, Calif., April 25, 2024 – Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced it has completed IND-enabling studies for its lead candidate, MIIST305. MIIST305 is being developed for two parallel programs, an indication for ulcerative colitis (UC) and a medical countermeasure for gastrointestinal acute radiation syndrome (GI-ARS). Within a year, Synedgen plans to open an Investigational New Drug (IND) application for MIIST305 and initiate a Phase 1 clinical study to support both programs. Derived from Synedgen’s Multivalent Immune Signaling Target (MIIST) platform, MIIST305 is an orally delivered, gut-restricted, tissue regenerative drug candidate.

Synedgen was awarded a $4.4 million grant from the Congressionally Directed Medical Research Program (CDMRP) to fund some of MIIST305’s preclinical, IND-enabling studies. Previously, MIIST305 demonstrated evidence of restoring innate gut barrier function and early return to a healthy GI tract, both in murine models of radiation exposure and UC. MIIST305 has an excellent safety and toxicological profile. With CDMRP support, Synedgen has now completed dose administration testing, pharmacokinetic (PK) studies, IND-enabling Good Laboratory Practice (GLP) toxicology, a pre-IND meeting with the FDA and safety pharmacology studies as well as validated processes for chemistry, manufacturing, and controls (CMC).

“The completion of IND-enabling activities represents a significant milestone in our progress towards developing a treatment option for UC patients, the civilian application for MIIST305,” said Shenda Baker, PhD, President and CEO of Synedgen. “We are grateful for the CDMRP funding that has enabled us to complete preclinical studies of MIIST305, which could address an unmet medical need for a drug capable of rapid induction and sustained maintenance in ulcerative colitis. MIIST305 also holds great potential as a GI-ARS medical countermeasure, with the potential to reduce mortality after exposure to lethal ionizing radiation. To date, we have had constructive conversations with the FDA in pre-IND meetings for both MIIST305 programs, and we are enthusiastic about the potential to advance both our UC and GI-ARS programs into the clinic.”

In the U.S., UC is estimated to affect 214 per 100,000 people (or approximately 700,000). The UC drug market was worth approximately $7.5 billion worldwide in 2020, constituting 10% of the total immunology market. With limited treatment options, high rates of non-responsive or refractory patients, and frequent disease flares, there is a large unmet need for new therapies.

“There is an urgent need for innovative therapies that target the underlying disease, instead of just managing symptoms, considering that less than 30% of patients with UC achieve remission,” said Brian Feagan, MD, a gastroenterologist and Professor of Medicine at the Schulich School of Medicine & Dentistry in Ontario, Canada. “With its novel mechanism of action, excellent safety profile, and potential for combination therapy, MIIST305 could provide a much-needed therapy for the patients and physicians dealing with UC.”

About MIIST

Synedgen’s Multivalent Innate Immune Signaling Target (MIIST) platform targets the glycocalyx, a key to human innate immunity. Historically an underappreciated target in drug development, the glycocalyx is becoming more recognized as the key to intestinal homeostasis. Developed with extensive peer-review and funding from government partners, the MIIST platform is being used to advance a diverse array of therapeutics promoting mucosal barrier protection and regeneration. The Company is continuing to develop its GI-ARS program with support from key partnering agencies in the United States government.

About Synedgen

Synedgen, Inc. (Claremont, CA) is a biotechnology company developing Multivalent Innate Immune Signaling Target (MIIST) therapeutics that modulate and enhance the innate immune system. The company’s lead development candidate is MIIST305, an oral, glycocalyx targeted induction and maintenance therapy for ulcerative colitis (UC). With US Government support, MIIST305 is also being developed in parallel as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI-ARS). MIIST technology has been validated with clinical trials in partnered programs and extensively peer-reviewed through twenty-two (22) National Institutes of Health grants and Department of Defense contracts. Synedgen has an in-house GMP manufacturing facility. For more information, please visit www.synedgen.com.

Contact:

Laurence Watts
619-916-7620
laurence@newstreetir.com

ALPHARETTA, GA, October 19, 2021 – Scapa Healthcare, an SWM International (NYSE: SWM) business and the trusted strategic partner for the world’s leading companies in advanced wound care, consumer wellness, and medical device and fixation, and Synedgen Inc., a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system, announced today that they have signed an exclusive worldwide licensing agreement for two novel innovative wound care treatments developed using Synedgen’s proprietary glycochemistry technology platform. The agreement also gives Scapa Healthcare the right to use Synedgen’s glycopolymer technology in conjunction with other wound care technologies.

Under the terms of the agreement, Scapa Healthcare has exclusive rights over Synedgen’s glycopolymer technology in the field of dermal wounds and surgical care applications both over the counter and in the professional setting.

The advanced glycopolymer-based wound cleanser and wound hydrogel formulae are proven to control infection and promote wound healing by limiting bacterial infection, disrupting mature biofilm, and reducing inflammation and scarring of acute and chronic wounds and surgical incisions. Developed with support from the Defense Health Agency (DHA) and the Defense Advanced Research Projects Agency (DARPA), these wound care products are FDA 510(k) cleared and offer substantial advances over existing wound cleansers and wound hydrogels products in the market.

In addition to the two market-ready products, this technology offers a wide range of possibilities for customized wound management solutions in combination with other advanced wound care technologies including hydrocolloids, hydrogels, collagen and medical foam materials.

“We are delighted to be entering into this agreement with Synedgen, a company that shares our commitment to deliver innovative medical solutions that truly enhance people’s lives” said John Petreanu, president of the Scapa Healthcare business. “This novel glycopolymer technology strengthens our portfolio of advanced wound care products and enables us to bring cutting-edge wound management solutions to our customers in a variety of formats leveraging our skin contact adhesive and topical technologies.”

“This agreement with Scapa Healthcare will expand Synedgen’s effective approach to treating challenging wounds for patients worldwide,” said Shenda Baker, PhD, President and CEO of Synedgen. “With a rich Defense heritage, we have been able to create a new class of wound care products for warfighter and civilian use. We are honored to partner with such a well-known, world industry leader that adds to the level of consumer trust and experience to expand the application and distribution of this technology.”

With development and manufacturing facilities throughout North America and Europe, Scapa Healthcare offers single-source, dual supply to its partners. Scapa Healthcare’s facilities are ISO-certified and FDA-registered with cleanrooms and environmentally controlled rooms for full-scale production of finished goods. In April 2021, Schweitzer-Mauduit International, Inc., known as SWM International, acquired Scapa Group PLC, including the Scapa Healthcare business.

About SWM International:

Schweitzer-Mauduit International, Inc., operating as SWM International, is a leading global performance materials company, focused on bringing best-in-class innovation, design, and manufacturing solutions to our customers. Our highly engineered films, adhesive tapes, foams, nets, nonwovens, and papers are designed and manufactured using resins, polymers, and natural fibers for a variety of industries and specialty applications. SWM and its subsidiaries manufacture on four continents, conduct business in over 90 countries and employ approximately 5,000 people worldwide. For further information, please visit SWM’s website at www.swmintl.com.

SWM’s Scapa Healthcare business is the trusted strategic partner of choice for the world’s leading companies in advanced wound care, consumer wellness and medical device & fixation. Our strategy is to collaborate with industry leaders to develop and manufacture innovative skin friendly medical device fixation and topical solutions. Through pursuing these collaborations, Scapa now provides integrated services to the top global MedTech companies. Our state-of-the-art facilities enable Scapa Healthcare to offer customers the whole spectrum of production services from inception through to market delivery. For more information visit: scapahealthcare.com or email healthcare@scapa.com

About Synedgen:

Synedgen is a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system. The company’s lead development candidate is SYGN305 for gastrointestinal mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer radiotherapy. Synedgen’s glycochemistry platform has already generated five FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 program, to Synspira, for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information, please visit www.synedgen.com.

SWM | Scapa Healthcare Media Contact
Hillary Lima
SVM Public Relations and Marketing Communications
hillary.lima@svmpr.com
(401) 490-9700

Synedgen, Inc. Media Contact
Laurence Watts
Gilmartin Group, LLC.
laurence@gilmartinir.com
(619) 916-7620

– Trial funded by Defense Health Agency (DHA) through US Army Medical Research and Development Command’s (USAMRDC) Small Business Innovation Research (SBIR) program –

– SynePure and Catasyn are FDA 510(k) cleared wound care medical devices –

CLAREMONT, Calif., August 5, 2021 – Synedgen, a biotechnology company using glycopolymer chemistry to develop therapeutics that enhance and control signaling in the innate immune system, today announced the initiation of a randomized controlled trial (RCT) to test the safety and effectiveness of SynePure™ Wound Cleanser (SynePure) in combination with Catasyn™ Advanced Technology Hydrogel (Catasyn) for the treatment of superficial partial-thickness burn wounds.

This study is an investigator-initiated randomized trial comparing SynePure and Catasyn (intervention group) to the current gold standard treatment, Silvadene (control group). Both groups will receive the same care other than cleansing treatment. Subjects will be recruited from the University of Pittsburgh Medical Center (UPMC) Mercy Burn Center adult patient population who have sustained superficial partial- thickness burn wounds. Dr. J. Peter Rubin, MD, the Chair of Plastic Surgery at UPMC, is the principal investigator for this study. The trial is being funded by the Defense Health Agency (DHA) through the US Army Medical Research and Development Command’s (USAMRDC) Small Business Innovation Research (SBIR) program to improve the current treatment of burn wounds, particularly to meet a gap in the early acute phase of treatment and will potentially increase the technological readiness level of these products.

“We’re excited to announce that the first patient has received treatment in the burn study,” said Shenda Baker, Ph.D., President and Chief Executive Officer of Synedgen. “We believe the combination of our two wound care products is not only safe but improves time-to-heal and infection rates in superficial partial-thickness burn wounds versus the current standard of care treatment. We are thankful to our partners at the DHA and USAMRDC for funding this important study, which we hope will introduce an improved standard of care for partial thickness burns.”

“Burn wounds are associated with significant morbidity and mortality as well as quality of life impairments for the patient. Burn wounds are particularly problematic, as they can compromise skin integrity, which can lead to infection,” said J. Peter Rubin, MD, UPMC Endowed Professor and Chair of Plastic Surgery and principal investigator for the study. “Moreover, thermal destruction of the skin provides an ideal environment for microbial colonization where, if left untreated, infection can spread to a systemic level. I am pleased to be leading this study and very much look forward to its findings.”

SynePure and Catasyn are Food and Drug Administration (FDA) 510(k) cleared wound care medical devices, formulated with a novel glycopolymer designed to be biocompatible and protective of dermal surfaces. SynePure is optimized for the cleansing and debridement of wounds and thermal injuries, while Catasyn is a protective gel dressing that provides an environment that supports wound healing. SynePure and Catasyn are biocompatible, shelf-stable up to two years, non-staining, and may be used in any care setting from the battlefield to a tertiary hospital.

Current Defense standard-of-care offers an array of antimicrobial, silver-based, stem cell, or autologous graft therapies which are normally deployed in the day(s) or week(s) following initial trauma. SynePure and Catasyn are first-in-class products can be used to treat initial trauma within the acute care gap of the minutes or hours immediately following traumatic injury. Immediate use following injury reduces time to healing, provides a protective barrier against infiltration by damage-causing microbes, and in some cases, reduces scar formation. Results from this RCT are expected not only to enhance choice of care available to warfighters, but also permit a significant enhancement in civilian care by bringing cutting-edge technologies to the patient bedside.

SynePure and Catasyn were developed with grants from the Army and DARPA (W81XWH-13-C-0053 and N66001-12-C-4053), with the RCT funded through SBIR contract W81XWH-16-C-0023 with the USAMRDC SBIR office.

About Synedgen

Synedgen is a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system. The company’s lead development candidate is SYGN305 for gastrointestinal mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer radiotherapy. Synedgen’s glycochemistry platform has already generated five FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 program, to Synspira, for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information, please visit www.synedgen.com.

Contact:

Laurence Watts

Gilmartin Group, LLC.

619 916 7620

laurence@gilmartinir.com

CLAREMONT, Calif. February 18, 2021 – Synedgen, a biopharma company dedicated to using its Multivalent Innate Immune Signaling Target (MIIST) platform to develop drugs that mimic and enhance the innate immune system, today announced that industry veteran Dennis Fenton, Ph.D., has joined Synedgen’s Board of Directors. Dr. Fenton is a prominent figure in the biotechnology industry and brings more than 30 years of experience in various roles such as operations, manufacturing and partnering.

“We are quite pleased that Dennis has chosen to join Synedgen’s board, given his breadth of experience and relationships in the biotech community and his leadership in successful drug development,” said Shenda Baker, CEO and President of Synedgen. “On behalf of Synedgen’s management and Board, I welcome Dennis and look forward to benefiting from his strategic, operational and clinical knowledge in the years to come.”

“I am excited to be joining Synedgen just as the company contemplates a number of key strategic and development decisions,” said Dr. Dennis Fenton. “During my thirty-plus-year career in biotechnology, I’ve had the opportunity to work with both big and small pharma, and I am particularly impressed by Synedgen’s MIIST platform and the multiple disease areas in which it has been and could be deployed.”

Dennis Fenton, Ph.D., is a member of the board of directors for AnaptysBio, Cirius Therapeutics and Modern Meadow. Previously, Dr. Fenton served on the board of directors of Hospira, Portola Pharmaceuticals, Dendreon, Genzyme, Kythera Biopharmaceuticals, XenoPort, Nora Therapeutics and Amira Pharmaceuticals. Dr. Fenton began his career at Pfizer as a senior researcher before joining Amgen in their first years of operations. Dr. Fenton worked at Amgen for 25 years and held several notable roles, including Executive Vice President, Operations at his retirement in 2008. Dr. Fenton received his Ph.D. in microbiology from Rutgers University.

About Synedgen

Synedgen Inc. is a privately held biopharma company that has developed a first-in-class Multivalent Innate Immune Signaling Target (MIIST) therapeutic platform. MIIST therapeutics target mucosal signaling in response to damage to control inflammation, regeneration and infection. Successes from this platform include SNSP113, a Phase 2 drug for Cystic Fibrosis out-licensed to Synspira Therapeutics, Inc. Synedgen’s internal lead asset is MIIST305, a clinic-ready, oral, immunomodulatory drug candidate that repairs GI injury by directing innate mucosal responses to restore GI function and reduce unchecked inflammation and damage. Synedgen is currently developing MIIST305 for the treatment of GI mucositis, a well-defined, acute injury, inflicted on the gastrointestinal tract by radiation and chemotherapeutics during cancer treatment. For more information, please visit www.synedgen.com.

Contact:

Laurence Watts

Gilmartin Group, LLC.

619 916 7620

laurence@gilmartinir.com

– Grant will fund understanding of the biochemical and biophysical structure of the endothelial glycocalyx –

– Synedgen’s CEO, Shenda Baker, gave a related keynote lecture at the Pan Pacific Connective Tissue Societies Symposium on November 25, 2020 –

CLAREMONT, Calif., December 10, 2020 – Synedgen, a biotechnology company using glycopolymer chemistry to develop drugs that enhance and control signaling in the innate immune system, today announced that UNSW in partnership with Synedgen has been awarded an A$600,633, 3-year, research grant from the Australian Research Council (ARC) to advance knowledge of the biochemical and biophysical structure of the endothelial glycocalyx. The resulting study will be the first to explore how charged glycopolymers interact with the endothelial glycocalyx with the goal of mapping the lifecycle of the network of membrane-bound proteoglycans and glycoprotein.

“Synedgen is developing molecules that interact with the glycocalyx to control the movement of cells and molecules across the endothelium and we are keen to deepen the understanding of the dynamic structure of, and implicit role of, the endothelial glycocalyx in innate immune signaling. This ARC-funded project aims to address this knowledge deficit by mechanistically elucidating and describing the dynamic lifecycle of the endothelial glycocalyx,” said Shenda Baker, Ph.D., President and Chief Executive Officer of Synedgen. “We are grateful to the ARC for this grant and honored to be working with Drs. Megan Lord and John Whitelock of the University of New South Wales, experts in proteoglycan interactions and signaling. We anticipate that results of these efforts can be leveraged to inform the development of targeted molecules to treat diseases involving the endothelial glycocalyx including cardiovascular and pulmonary diseases, stroke and traumatic brain injury.”

“We still have much to learn about the structure and dynamics of the endothelial glycocalyx, a network of proteoglycans and glycosaminoglycans anchored at the cell surface,” said Megan Lord, Ph.D., lead PI on the grant. “Synedgen’s glycopolymers will enable us to study interactions at the endothelial interface and develop new ways to support endothelial functions.”

Synedgen believes the findings of the ARC-sponsored project will inform the company’s future research and development activities over the next 3-7 years.

Synedgen’s CEO, Shenda Baker, gave a related keynote lecture at the Pan Pacific Connective Tissue Societies Symposium on November 25, 2020, titled, “Glycopolymer interactions with the glycocalyx to modulate innate immune responses after dermal injury.” The 12th Pan Pacific Connective Tissue Societies Symposium, a virtual event held in November 2020, was held in conjunction with the scientific meetings of the Australian Wound & Tissue Repair Society (AWTRS) and Matrix Biology Society of Australia and New Zealand (MBSANZ).

About Synedgen

Synedgen is a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system. The company’s lead development candidate is SYGN305 for gastrointestinal mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer radiotherapy. Synedgen’s glycopolymer platform has already generated five FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 program, to Synspira, for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information please visit www.synedgen.com.

Contact:

Laurence Watts

Gilmartin Group, LLC.

619 916 7620

laurence@gilmartinir.com

– Additional funding increases cumulative NEI commitment to over $1 million –

– All selected molecules synthesized under this initiative have met prerequisite development criteria –

CLAREMONT, Calif. October 29, 2020 – Synedgen, a biotechnology company using glycopolymer chemistry to develop drugs that enhance and control signaling in the innate immune system, today announced supplemental funding from the National Eye Institute (NEI) of the NIH to identify a lead molecule from the company’s ocular mustard gas injury program to move into animal studies.

Synedgen has developed a new class of glycopolymers with the ability to suppress inflammation, reduce infection, and improve healing at mucosal surfaces. To date, Synedgen has utilized NEI-funding to synthesize and test a suite of new molecules, using the company’s proprietary glycopolymer platform, with the potential to treat the acute and chronic effects of ocular chemical toxicity. Synedgen today announced that all of the selected molecules under this effort have met the prerequisite criteria for cell surface association, cellular regeneration and anti-inflammatory activity to move forward into the next phase of testing. The additional funding from the NEI provides resources to optimize down-selection to a lead molecule to advance into animal studies.

“We are thankful for the NEI’s continued support of our ocular mustard gas injury program, which has added a number of active novel glycopolymers to our library,” said Shenda Baker, Ph.D., President and Chief Executive Officer of Synedgen. “By targeting the unique environment of the corneal surface, we have created a new suite of molecules with the potential to target an expanded range of ocular indications. These molecules have good residence time in the eye, and provide a unique barrier function that is similar to the eyes’ natural tear layer.  In addition, they are designed to encourage healing, reduce inflammation and significantly decrease corneal fibrosis, which is a proxy for vision loss.”

Synedgen’s ocular mustard gas injury program supports development of a potential treatment for military and civilian ocular injuries caused by sulfur mustard (SM). SM is employed as a chemical weapon, and its increasing production and use in unstable regions throughout the world heightens the risk that it could one day be used in a terrorist attack against U.S. civilians or armed forces, potentially causing severe burns to the eyes, skin and respiratory tract. The ocular surface is uniquely susceptible to SM, resulting in corneal lesions, edema, ulceration, neovascularization and vision loss. There are currently no FDA-approved drugs for SM-induced ocular injuries to improve healing and reduce vision loss.

The supplemental funding announced today facilitates the assessment of the optimized molecules in an ocular tissue model consisting of normal human corneal epithelial cells cultured to form a stratified, squamous epithelium which closely parallels normal human corneal tissue. The corneal cells differentiate to form a multi-layered structure with metabolically active tissue having barrier properties similar to the human cornea and are used to predict activity in the human cornea. Using this data, Synedgen plans to select a lead development candidate to progress into animal trials.

About The Award

Research reported was supported by the National Eye Institute (NEI/NIH) and the NIH Office of the Director (OD) under Award Number U01EY030406. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Synedgen

Synedgen is a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system. The company’s lead development candidate is SYGN305 for gastrointestinal mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer radiotherapy. Synedgen’s glycopolymer platform has already generated five FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 program, to Synspira, for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information please visit www.synedgen.com.

Contact:

Laurence Watts

Gilmartin Group, LLC.

619 916 7620

laurence@gilmartinir.com

– Synvaza is an oral treatment that manages pain and promotes healing for many types of oral wounds, injuries, and ulcers –

– Premium addition to Prisyna, Synedgen’s oral health portfolio, which includes Moisyn® and Moisyn® Mist for dry mouth –

CLAREMONT, Calif. June 4, 2020 – Synedgen, a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Synvaza Mouth Sore and Wound Rinse over-the-counter (OTC). Synvaza is the most recent addition to Synedgen’s oral health care business unit, Prisyna, which already includes Moisyn and Moisyn Mist for dry mouth, as well as Synedent® and Synedent® FLX oral rinses.

“The Agency’s clearance of Synvaza provides a new and effective treatment option that helps manage pain while promoting healing for patients who suffer from painful ulcers and mouth sores of the oral mucosa. Synvaza also provides an innovative solution for patients with many types of oral wounds, including traumatic ulcers and surgical injuries,” said Shenda Baker, Ph.D., President and Chief Executive Officer of Synedgen. “With Prisyna’s multiple offerings, Synedgen is uniquely positioned to improve oral health across multiple patient segments.”

Prisyna’s oral care portfolio contains cutting-edge ChitoTek® technology, which has been developed using Synedgen’s proprietary glycochemistry platform. Synvaza is an oral wound rinse formulated with ChitoTek, mucoadhesive, hygroscopic biopolymers that form a protective barrier around oral wounds to prevent irritation and help manage pain. This formulation provides a moist wound environment, which is optimal for wound healing.

In a clinical study, Synvaza was shown to decrease pain associated with ulcerative oral lesions. Patients reported decreases in oral soreness related to drinking, swallowing, eating, talking, and sleeping. Pain relief was reported by patients including those with aphthous stomatitis, oral lichen planus, and chronic graft versus host disease. Studied lesions were associated with medications, cancer treatment, acid reflux, and other underlying conditions.

Synedgen’s glycochemistry platform is also being used to develop therapeutics for pulmonary and gastrointestinal diseases, as well as for ocular and dermal injuries. Synedgen has developed its technology with support from the Defense Advanced Research Projects Agency (DARPA), Defense Health Agency (DHA), Medical Research and Materiel Command (MRMC), and six institutes of the National Institutes of Health. We formally thank the National Institute for Dental and Craniofacial Research (R44DE019740) for supporting Synvaza’s development.

About Award

The project described was supported by Award Number R44DE019740 from the National Institute Of Dental & Craniofacial Research. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Dental & Craniofacial Research of the National Institutes of Health.

About Synedgen

Synedgen is a biotechnology company using glycochemistry to develop therapeutics that mimic and enhance the innate immune system. The company’s lead development candidate is SYGN305 for gastrointestinal mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer radiotherapy. Synedgen’s glycochemistry platform has already generated seven FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 drug program, to Synspira (Framingham, MA), for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information, please visit www.synedgen.com.

Contact:

Laurence Watts

Gilmartin Group, LLC.

619 916 7620

laurence@gilmartinir.com

– Funds commercialization and head-to-head clinical trial against current standard of care –

– Also announces abstract at 9th RAND Corporation and Department of Defense State-of-the-Science Meeting on Blast-Related Burn Injury Research –

CLAREMONT, Calif. March 3, 2020 – Synedgen, a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system, today announced a combined $1 million award from the Defense Health Agency (DHA) Small Business Innovation Research Program (SBIR), along with additional research funds from the DHA, to commercialize its products, SynePure™ Wound Cleanser (SynePure) and Catasyn™ Advanced Technology Wound Hydrogel (Catasyn), developed under DHA SBIR award W81XWH-16-C-0023, and to perform a randomized clinical trial comparing them to the current standard of care in patients with partial thickness (2nd degree) burns. Synedgen has chosen the University of Pittsburgh Medical Center (UPMC) Mercy Trauma and Burn Center as its subcontractor for the clinical program.

“Bringing these products to patients is the realization of Synedgen’s commitment to finding solutions for intractable and unmet needs in infection, inflammation and healing,” said William Wiesmann, MD, Executive Chairman of Synedgen’s Board. “Both military and civilian burns are typically chronically infected and inflamed, often leading to disfiguring scars. This funding allows us to quickly advance our products into patients, where we anticipate increased healing rates with reduced fibrosis, even in wounds with multi-drug resistant bacteria. We would like to formally thank our sponsors at the DHA for their assistance to date.”

Development of SynePure and Catasyn has been funded by the DHA as well as the Defense Advanced Research Projects Agency (DARPA) SBIR Program. Both products are Food and Drug Administration (FDA) 510(k) cleared medical devices formulated with glycopolymers from Synedgen’s platform.

Additionally, Synedgen today announced a presentation to be given at the 9^th Department of Defense State-of-the-Science Meeting on Blast Injury Research. The meeting is co-sponsored by  the RAND Corporation and the Department of Defense (DoD) Blast Injury Research Coordinating Office (BIRCO) and titled “Mitigating the Impact of Blast-related Burn Injuries: From Prolonged Field Care to Rehabilitation and Resilience”, will take place in Arlington, Virginia, on March 3-5, 2020.

Kaveri Parker, Ph.D., Synedgen’s Chief Business Officer, will give an oral presentation detailing the company’s solutions for polytraumatic combat injuries resulting from explosive device detonation, the management of which poses unique patient- and field-management challenges. Synedgen has developed SynePure and Catasyn to provide a burn injury treatment portfolio capable of managing these care considerations. SynePure has been optimized for the cleansing of wounds and thermal injuries, while Catasyn serves as a protective gel dressing.

About Synedgen

Synedgen is a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system. The company’s lead development candidate is SYGN305 for gastrointestinal mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer radiotherapy. Synedgen’s glycochemistry platform has already generated five FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 program, to Synspira, for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information please visit www.synedgen.com.

Contact:

Laurence Watts

Gilmartin Group, LLC.

619 916 7620

laurence@gilmartinir.com

– First results from ocular injury program to treat damage from sulfur mustard gas –

– Announces $1 million funding from the National Eye Institute for continuation of program development –

CLAREMONT, Calif. February 18, 2020 – Synedgen, a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system, today announced a poster presentation at the upcoming National Institutes of Health  (NIH)-organized scientific meeting, “Developing Medical Countermeasures To Treat the Acute and Chronic Effects of Ocular Chemical Toxicity”. The meeting will take place in Rockville, Maryland, on February 25-26, 2020.

Poster Presentation:

Title: Improving Corneal Wound Healing After Chemical Injury With Novel Therapeutic Glycopolymers

Presenter: Shenda Baker, Ph.D.

Date: Tuesday, February 25, 2020

Time: 2:00 p.m. – 3:00 p.m. ET

Location: National Institute of Allergy and Infectious Diseases (NIAID/NIH) Conference Center, 5601 Fishers Lane, Rockville, Maryland 20852

“We’re excited to share this promising data from Synedgen’s ophthalmic glycopolymer candidates, given the lack of effective drugs for this type of damage to the eye,” said Dr. Brian Gilger, study lead and Professor of Ophthalmology at North Carolina State University College of Veterinary Medicine. “Importantly, the new molecules from Synedgen’s glycopolymer platform have the potential not only to provide a powerful countermeasures solution, but also to be applied in the civilian market where corneal damage is a frequent cause of vision loss.”

Sulfur Mustard (SM) is employed as a chemical weapon, and its increasing production and use in unstable regions throughout the world heightens the risk that it could be used in a terrorist attack against U.S. civilians or armed forces, potentially causing severe burns to the eyes, skin and respiratory tract. The ocular surface is uniquely susceptible to SM, resulting in corneal lesions, edema, ulceration, neovascularization and vision loss. There are currently no FDA-approved drugs for SM-induced ocular injuries to improve healing and reduce vision loss.

Synedgen has developed a class of glycopolymers with the ability to suppress inflammation, reduce infection, and improve healing at mucosal surfaces. One such glycopolymer reduces epithelial damage and inflammation in an animal model of potassium hydroxide (KOH)-induced ocular injury. This glycopolymer was well-tolerated, with reduced initial ocular inflammation (measured by Hackett-McDonald ocular scores) at 12 hours, and lower subsequent cumulative ocular inflammation. Furthermore, relative to control, the treatment prevented significant secondary ulceration, improved the healing rate and reduced corneal fibrosis. Given these results, preliminary optimization of five related compounds has been initiated in order to optimize the therapeutic efficacy of lead molecules against SM burns. This program is being funded by a three-year $970,000 award from the National Eye Institute (NEI/NIH) and the NIH Office of the Director (OD). The award is specifically earmarked for the “Identification of lead compounds to topically treat sulfur mustard injury to reduce ocular damage and improve vision.”

About Award

Research reported was supported by the National Eye Institute (NEI/NIH) and the NIH Office of the Director (OD) under Award Number U01EY030406. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Synedgen

Synedgen is a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system. The company’s lead development candidate is SYGN305 for gastrointestinal mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer radiotherapy. Synedgen’s glycochemistry platform has already generated five FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 program, to Synspira, for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information please visit www.synedgen.com.

Contact:

Laurence Watts

Gilmartin Group, LLC.

619 916 7620

laurence@gilmartinir.com

– Glycopolymers aimed at reducing inflammation and damage associated with ulcerations of the lower bowel –

CLAREMONT, Calif. December 13, 2019 – Synedgen, a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system, today announced the award of a competitive Congressionally Directed Medical Research Program (CDMRP) contract. Administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA), this award enables Synedgen to optimize therapeutic treatments that restore innate gastrointestinal (GI) integrity damaged by inflammatory bowel diseases (IBD).

Synedgen plans to use the $259k grant to complete preclinical efficacy studies for several formulations of its proprietary glycopolymer pharmaceuticals to reduce GI inflammation, leaky bowl syndrome, and ulcerative damage in a model of ulcerative colitis (UC).

“This award enables Synedgen to further expand its growing portfolio of glycopolymer therapeutics designed to treat damage to, and inflammatory conditions of, mucosal surfaces like the GI tract,” said Shenda Baker, CEO and President of Synedgen. “Our surface-active glycopolymers have broad mechanisms of action and have been shown to reduce inflammation and tissue damage in animal models of IBD and radiation injury. The studies planned under this award are designed to optimize the drug molecular structure and dosing prior to clinical development. We would like to formally express our gratitude to USAMRAA for this grant.”

Synedgen has developed several derivatives of its proprietary high molecular weight glycol-polymer therapeutics that reduce inflammation, improve healing and restore integrity along the length of the GI tract. Synedgen’s orally delivered GI treatments have demonstrated a robust ability to reduce local and systemic inflammation, lessen cell death, and improve tissue regeneration associated with chemical, physical and radiation-induced damage in the large and small intestines in animal models that mimic conditions seen in human UC and Crohn’s disease.

About IBD

IBD generally describes disorders that involve chronic inflammation of the digestive tract. Types of IBD include UC, which causes long-lasting inflammation and sores (ulcers) in the innermost lining of the large intestine and rectum, and Crohn’s disease, which is characterized by chronic inflammation of the lining of the digestive tract. Both UC and Crohn’s disease usually involve severe diarrhea, abdominal pain, fatigue and weight loss. Although they are separate conditions, they share common features of intestinal inflammation and ulceration and significant reduction in quality of life for IBD patients. In a healthy gut, the GI microenvironment can auto-regulate and maintain a stable state with the normal bacterial flora and support an intact gut barrier. The intestine normally controls permeability, allowing nutrients to pass through while also maintaining a barrier function to keep potentially harmful substances and bacteria from migrating more widely into the body. In a damaged or inflamed gut, such as in patients with IBD, dysfunction of the mucosal barrier allows penetration of both “good” and “bad” microbes onto and through the intestinal cell wall and into circulation which can lead to severe systemic complications.

About the Award

The U.S. Army Medical Research Acquisition Activity, 839 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work was supported by the Assistant Secretary of Defense for Health Affairs, through the Peer Reviewed Medical Research Program under Award No. W81XWH-19-1-0165. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. In conducting research using animals, the investigators adhere to the laws of the United States and regulations of the Department of Agriculture.

About Synedgen

Synedgen is a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system. The company’s lead development candidate is SYGN305, for GI Mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer therapy. Synedgen’s glycochemistry platform has already generated five FDA 510(k) cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 program, to Synspira, for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information please visit www.synedgen.com.

Contact:

Laurence Watts

Gilmartin Group, LLC.

619 916 7620

laurence@gilmartinir.com

CLAREMONT, Calif. – October 10, 2018 –  Synedgen, a company leveraging its proprietary glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory conditions, today announced the market launch of Moisyn™ Rinse for the treatment of the symptoms of xerostomia, or dry mouth. Moisyn Rinse is being distributed by Prisyna, the oral care division of Synedgen.

The Moisyn product line is the first glycomics targeted therapy that has been shown in a clinical study to reduce pain and increase comfort for patients living with dry mouth¹. Moisyn products, including Moisyn Mist, the convenient spray formulation, provide advanced relief from the symptoms of dry mouth while moisturizing and lubricating the oral cavity.

“The introduction of Moisyn Rinse is part of Synedgen’s commitment to improving oral health based on the benefits of our glycomics technology,” said Shenda Baker, Ph.D., President and Chief Operating Officer of Synedgen. “The Synedent® and Moisyn family of products demonstrate the value that glycomics can bring to addressing important unmet patient needs. We are bringing that same commitment to addressing other inflammatory and infectious diseases associated with the mucosal interface utilizing the promise of glycomics to improve human health.”

“The commercial launch of Moisyn Rinse is another milestone for Prisyna and our dedicated team,” said Leo Pranitis, General Manager of Prisyna. “Moisyn provides relief for the symptoms of dry mouth, a condition which is associated with tooth decay, disturbed sleep, oral infections and a range of other oral health problems. The glycomicstechnology that differentiates both our Moisyn and Synedent family of products is unique, truly innovative and most importantly, addresses a need that is not currently being fully met by the product offerings on the market.”

About Xerostomia (Dry Mouth)

Xerostomia, or dry mouth, causes dryness in the oral cavity, most commonly the tongue and roof of the mouth. Typically, it is identified by a reduction or absence of oral saliva and can be brought on by a variety of conditions, including aging. Over 1000 prescription and non-prescription medications, including drugs for treating anxiety, depression, high blood pressure, allergies, and cancer are known to alter the production of saliva and cause dry mouth as a side effect.

Common problems stemming from dry mouth include tooth decay, disturbed sleep, dry throat, burning sensation in the throat, gum disease, oral infections, taste change, and difficulty speaking and swallowing.

About Synedgen

Synedgen is developing a new class of health care products based on glycomics, a revolutionary approach using glycopolymers to target mucosal and dermal interfaces. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surfaces. Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as SNSP113, which has been licensed to Synspira and is currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.https://synedgen.com/

About Prisyna

Prisyna, the oral healthcare division of Synedgen, is developing and commercializing a new class of oral health care products based on glycomics, a revolutionary approach using natural glycopolymers to target the mucosal interface. Prisyna uses this unique technology to develop oral health care products that clean the mouth, reduce pain and irritation on sensitive mucosal surfaces and improve overall oral health. Prisyna is building a family of environmentally safe products using cutting edge science to promote healthy teeth, gums and oral surfaces.  http://www.prisyna.com/

¹Oral Surg Oral Med Oral Pathol Oral Radiol. 2017 Jan;123(1):76-83. doi: 10.1016/j.oooo.2016.09.008. Epub 2016 Sep 28.

CLAREMONT, Calif.- September 19, 2018 – Synedgen, a company leveraging its proprietary glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory conditions, today announced the appointment of Kaveri Parker, Ph.D. as Chief Business Officer. In her role, she will lead the business development and commercialization of Synedgen’s inflammatory and infectious disease programs as well as advance strategic partnership opportunities across Synedgen’s wound care product portfolio. Dr. Parker will also assist with business development for the Prisyna oral care division of Synedgen.

“Kaveri is an accomplished business executive with a deep scientific background and we are thrilled to welcome her to our team,” said Shenda Baker, Ph.D., President and Chief Operating Officer of Synedgen. “Her scientific training and business development experience along with her keen and rapid assessment of market opportunity and positioning will play a critical role in our growth strategy as we continue to develop our product portfolio.”

“Synedgen’s glycomics technology platform has the potential to fundamentally change how we treat infectious and inflammatory diseases,” said Dr. Parker. “I am excited to join Synedgen at a pivotal point in this organization’s growth and look forward to working with the accomplished management team to bring several FDA-cleared products to market and leverage our existing technologies for sustained growth.”

With SynePure^TM Wound Cleanser and Catasyn^TM Advanced Technology Wound Hydrogel having received FDA clearance for marketing, Synedgen Wound Care is a leader in applying glycomics to manage and improve wound care. Synedgen Wound Care products are developed to support a healthy environment for healing without the use of harsh chemicals that can cause further pain and inflame damaged tissue.

Prisyna, the oral care division of Synedgen, has received FDA clearance to market Moisyn^® to treat symptoms of dry mouth, which adds to the portfolio including Synedent^® and Synedent FLX^® oral rinses. The goal of Prisyna’s scientifically-driven formulations is to develop oral health care products that clean the mouth, reduce pain and irritation on sensitive mucosal surfaces and improve overall oral health.

Synedgen has other programs in early development that use the company’s glycomics platform in therapeutics to:

• reduce damage and inflammation due to chemical, radiological or physical damage,
• manage infection, inflammation and ulcers in the gastrointestinal tract,
• target the host-pathogen interface utilizing novel mechanisms to reduce the challenge of antibiotic resistance, and
• provide a barrier to infection and improved healing in the eyes.

Dr. Parker has an extensive background in biochemistry and infectious diseases, as well as years of business development and management experience. Most recently, she served as President and Chief Executive Officer of ID Genomics where she led all aspects of executive management, including investor and media relations, management and scientific team building, strategic and tactical planning, fundraising, and path-to-market strategy. During her tenure, she secured strategic partnerships with 12 major clinical hospital networks across the U.S. and managed ID Genomics’ regulatory and intellectual property development.  Prior to her tenure as President and Chief Executive Officer at ID Genomics, she served as Director of Operations. Dr. Parker earned her Ph.D. in biochemistryat Washington University and a Bachelor of Science in biochemistry at the University of New Mexico.

About Synedgen

Synedgen is developing a new class of health care products based on glycomics, a revolutionary approach using glycopolymers to target mucosal and dermal interfaces. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surfaces. Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as SNSP113, which has been licensed to Synspira and is currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.

— Synvaza reduces pain associated with erosive or ulcerative oral lesions —

CLAREMONT, Calif. – July 11, 2018 – Prisyna, the oral care division of Synedgen, founded to optimize oral health using advanced, proprietary glycomics technology, today announced new research showing that Synvaza®, an oral rinse product, reduced mucosal pain without anesthetic effect and improved oral function in patients with ulcerative oral mucosal lesions. The study, “Efficacy of a glycopolymer-based oral rinse upon pain associated with ulcerative and erosive lesions of the oral mucosa: A within-subject pilot study,” was published in Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology.

The pilot study was powered to evaluate the efficacy of Synvaza in reducing pain associated with existing erosive or ulcerative lesions of the oral mucosa and to understand the magnitude of the effect on pain reduction in order to power future studies. Results showed that Synvaza significantly reduced severity in all measures of oral soreness from baseline to 72 hours.

Twenty-five subjects with ulcerative/erosion lesions and moderate pain were enrolled in this open label study. They were provided with a 72-hour supply of Synvaza and instructed to use as needed for 72 hours with a minimum frequency of two times per day, swished for one minute at each use, with the first dose used upon awakening and the last dose just before bedtime. At the start of the study, and 24, 48 and 72 hours after first product use, subjects completed surveys in which they documented pain scores and oral symptoms, including mouth and throat soreness, domain-specific problems with eating, drinking, swallowing, talking, sleeping, and general symptoms of dry mouth and mouth and throat lining sensitivity and pain. Ratings ranged from zero, representing an absence of symptoms, to ten, representing the most severe degree of symptoms.

The overall soreness score showed a continuous decline across the four-time points and all of the oral soreness scores had a statistically significant decrease from baseline to 72 hours. The largest domain-specific decrease from baseline to 72 hours was for oral soreness associated with talking (67%), followed by drinking (62%), swallowing (56%), sleeping (51%), and eating (50%). Overall soreness from baseline to 72 hours decreased by 28%.

“The study showed reductions in mouth or throat pain, changes in dry mouth and sensitivity of the lining of the mouth and throat to spicy, hot or acidic foods, which may represent a meaningful improvement in quality of life for patients,” said lead author Joel B. Epstein, DMD, MSD. “Additionally, early pain reduction was commonly reported, with a cumulative effect that appeared to increase with successive rinse applications for the duration of the study, implying a potentially broad range of effect upon painful oral mucosal conditions.”

“Synvaza addresses the needs of patients who suffer from the pain of oral lesions, which can have a substantial negative effect on their daily routine and in more acute circumstances can be quite debilitating,” stated Leo Pranitis, Prisyna General Manager. “We look forward to the continued study and development of Synvaza to potentially provide relief for patients suffering from ulcerative oral mucosal lesions as part of our commitment to addressing a broad range of patient oral care needs using our innovative glycomics technology.”

Disclosure: Synedgen Inc. provided funding for this research and contributed to the protocol design, development and manuscript. Data were analyzed and interpreted independently. The National Institutes of Health / National Institute of Dental & Craniofacial Research supported oral mucositis research under Grant Number:2R44DE019740-02.

May 23, 2018–Synedgen, a company leveraging its proprietary glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory conditions, today announced that it has received 510(k) clearance from the U. S. Food and Drug Administration (FDA) to market its Catasyn™ Advanced Technology Wound Hydrogel both under the direction of a health care professional and over-the-counter (OTC).

“This FDA clearance for Catasyn provides patients with a new option to treat both minor burns and skin lacerations and physicians with an alternative to treat more severe dermal ulcers, post-operative incision sites and second degree burns,” said Shenda Baker, Ph.D., President and Chief Operating Officer of Synedgen. “Catasyn has been developed using our Glycomics Technology Platform to provide a moist wound environment that supports healing. We look forward to making Catasyn commercially available as we continue to develop new products to improve care for oral, dermal and mucosal lesions and wounds.”

When administered by a healthcare professional, Catasyn can be used for the dressing and management of partial to full thickness dermal ulcers including pressure sores, venous stasis ulcers, arterial ulcers and diabetic ulcers, surgical wounds including post-operative incisions and donor sites and superficial and partial thickness (second degree) burns. In its OTC indication, Catasyn can be used for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.

“Catasyn development was supported by the U.S. Army with the goal of creating a product that can help speed wound healing and mitigate infection risk in soldiers,” said William Wiesmann, M.D., Chief Executive Officer of Synedgen. “While it was tailored to the needs of the military for indications such as postoperative wounds and traumatic, thermal, chemical and radiation wounds and burns, Catasyn is also applicable for the civilian population.”

Synedgen is developing its wound care portfolio based on the science of glycomics to provide superior wound cleansing and a barrier to infection. Synedgen aims to develop products that support a healthy environment for healing without the use of harsh and abrasive chemicals that can cause further pain and inflammation to damaged tissue. Catasyn is the third marketed product in Synedgen’s wound care portfolio which includes SynePure Wound Cleanser for the cleansing of dermal wounds as well as Synoplex for veterinary indications.

About Synedgen

Synedgen is developing a new class of health care products based on glycomics, a revolutionary approach using glycopolymers to target mucosal and dermal interfaces. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surfaces. Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as SNSP113, which has been licensed to Synspira and is currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.

— Experienced healthcare executive to build oral health franchise and expand Prisyna brand —

CLAREMONT, Calif. – April 17, 2018 – Prisyna, the oral care division of Synedgen, founded to optimize oral health using advanced, proprietary glycomics technology, today announced the appointment of Leo Pranitis as General Manager. He will lead the commercialization and expansion of Prisyna’s product portfolio, including the Synedent™ family of products made of naturally-derived, environmentally compatible ingredients that disrupt oral contaminants, remove harmful debris, and promote healthy teeth and gums.

“As our oral care portfolio expands, we are very pleased to bring Leo Pranitis on board to grow the Prisyna brand and build consumer adoption of its products,” said Shenda Baker, Ph.D., Synedgen President and Chief Operating Officer. “Leo is a highly experienced oral care marketing professional with a proven track record of creating and executing intelligent commercialization campaigns that reach patients who can benefit from improved oral care products.”

Mr. Pranitis commented, “Synedgen’s innovative and ground-breaking glycomics platform is dedicated to delivering outstanding benefits to both patient and health care providers. As General Manager of Prisyna, I am thrilled to have the opportunity to bring this exciting science to meet the oral care needs of patients and I look forward to introducing new oral care products as we continue to build on the science of glycomics.”

Mr. Pranitis has over 30 years of professional experience in various commercial roles, primarily within the dental industry. He has built and led sales, marketing and R&D teams that have produced award-winning, market-leading products, several of which continue to hold premier market share positions within the global dental market. Previous roles include Vice President of Sales & Marketing, North America, for Southern Dental Industries, Vice President, Sales & Marketing for Sonendo, and Vice President, Global Marketing and Innovation at Kavo Kerr (previously, Kerr Dental), a Danaher company. Mr. Pranitis holds a B.A. from Northern Illinois University, and is the co-inventor of the world’s first single dose dental adhesive system.

February 15, 2018–Synedgen announces the appointment of Allister J. Loughran, PhD as Senior Scientist to lead its research operations and to expand research indications for its platform of biologically active glycopolymers in areas of infectious disease, systemic inflammation and the innate immune response to injury or exposure.

“Our research indicates that there are far reaching applications for Synedgen’s family of glycopolymers to reduce microbial invasion and inflammation and enhance innate immunity” stated Dr. William Wiesmann, M.D., Synedgen CEO.  “Dr. Loughran brings us a unique experience and expertise in the models, systems and experimental design that we are expanding to conduct the pre-clinical research necessary to develop these potentially important drugs”.

We are particularly excited that  Dr. Loughran’s training and expertise in bacterial infection and inflammation models will be instrumental as Synedgen develops new products focused on the interplay between bacterial interactions and mucosal or dermal injury with the innate immune system and regenerative processes.  ” said Synedgen President, Dr. Shenda Baker.

“Dr. Loughran will provide scientific leadership and oversight as Synedgen continues its therapeutic product expansion. His experience in designing in vitro assays to predict and direct clinically meaningful in vivo studies will support a broad expansion of our drug development vision,” added  Dr.  Baker.

Dr. Loughran previously served as a Postdoctoral Research Associate at St. Jude Children’s Research Hospital,
Infectious Diseases Department, in Memphis TN, where he investigated a broad range of related infectious and injury models that included the effects of bacterial products released in response to antibiotic treatment on inflammation in developing brains.

Dr. Loughran earned his PhD in Microbiology/Immunology at the University of Arkansas for Medical Sciences, and his BSc. in Microbiology and Molecular biology at Monash University, Australia. 
He conducted his Doctoral Research at the University of Arkansas for Medical Sciences, where he studied  the potential of the Staph aureus gene product , sarA, to become a  drug target in a number of bacterial infections, including sepsis and osteomyelitis.

About Synedgen

Synedgen Inc. is developing a new class of drugs with the ability to suppress inflammation, reduce infection and improve healing in the gastrointestinal tract and pulmonary tree and to reduce damage and inflammation due to chemical, radiological or physical damage using the science of glycomics – the study of complex sugar structure and function. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surface.

Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as inhaled pulmonary drugs, which have been licensed to Synspira with SNSP113 currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.

— New understanding of role of ions could impact treatment of infectious and inflammatory diseases —

CLAREMONT, Calif.-January 31, 2018–Synedgen, a company leveraging its proprietary glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory disorders associated with the mucosal membranes of the gastrointestinal tract, today announced that research elucidating the role of complex sugars and ions and their potential role in the treatment of diseases was published in the journal, Macromolecular Theory and Simulation.

The paper, “A Continuum Model of Mucosa with Glycan-Ion Pairing” by Shenda Baker, Ph.D., President and Chief Operating Officer at Synedgen and James Sterling, Ph.D., Professor of Applied Life Sciences at the Keck Graduate Institute, describes the role that differences in ion interactions at the cellular level play in driving diseases affecting the mucosal interface and suggests potential therapeutic approaches. This work follows a 2017 publication by Drs. Baker and Sterling in Colloid and Interface Science Communications, titled “Electro-lyotropic equilibrium and the utility of ion-pair dissociation constants,” which established the feasibility of these models for biohydrogel structure determination.

Complex sugars known as glycans are some of the most negatively-charged molecules in biology and coat cell and mucosal surfaces, most notably in the nose, throat, eyes, lungs and gastrointestinal tract to protect against pathogens. Due to lyotropy, the observation that various positive ions with the same charge have different interactions with a negatively charged ion, glycans interact in unique ways with each type of ion. These differences cause small changes in relative ion concentrations to result in large changes in both the electrical potential and the thickness of the glycan layer that protects cells from pathogen attachment and invasion.

“With this study, we were able to contemplate ion interactions and electrical potentials in a variety of biologically important hydrogels and cell surfaces and calculate specific ion-ion interactions for each ion pair type,” said Dr. Sterling. “Understanding how each type of ion affects the structure, electrical potential and fluid behavior of the mucosal surface layers are effects that could be considered when developing treatments for diseases associated with or affecting the mucosal interface.”

In mucosal surfaces, such as the lung and gastrointestinal tract, the mucus is comprised of negatively charged polyelectrolytes called mucins that are very sensitive to changes in ions. In patients with cystic fibrosis, for example, the genetic defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene reduces ion transport, causing thick and viscous mucus.

“This study shows the impact glycans and ions have on infectious disease and immune response. At Synedgen, we are harnessing this work to develop new glycopolymer-based therapeutics to prevent and treat infections,” stated William Wiesmann, M.D., Chief Executive Officer of Synedgen. “Our first glycopolymer approach is currently being studied in a Phase 1 clinical trial of SNSP113 in cystic fibrosis by Synspira, which has in-licensed our technology for applications in the treatment of pulmonary diseases.”

About Synedgen

Synedgen Inc. is developing a new class of drugs with the ability to suppress inflammation, reduce infection and improve healing in the gastrointestinal tract and pulmonary tree and to reduce damage and inflammation due to chemical, radiological or physical damage using the science of glycomics – the study of complex sugar structure and function. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surface.

Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as SNSP113, which has been licensed to Synspira and is currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.

About the Keck Graduate Institute

Keck Graduate Institute (KGI) was founded in 1997 as the first higher education institution in the United States dedicated exclusively to education and research related to the applied life sciences. KGI offers innovative postgraduate degrees and certificates that integrate life and health sciences, business, pharmacy, and genetics, with a focus on industry projects, hands-on industry experiences, and team collaboration. A member of The Claremont Colleges, KGI employs an entrepreneurial approach and industry connections that provide pathways for students to become leaders in bioscience and healthcare. www.kgi.edu

Contacts

MacDougall Biomedical Communications
Amanda Houlihan, 781-235-3060
ahoulihan@macbiocom.com

CLAREMONT, Calif. – October 27, 2016 – Synedgen, a company leveraging a unique proprietary glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory disorders associated with the lung, skin and mucosal membranes, today announced the presentation of preclinical data demonstrating that treatment with a proprietary modified polysaccharide molecule in an in vivo model of cystic fibrosis prevented the development of distal intestinal obstructive syndrome (DIOS). Data from these studies demonstrated improved survival and growth in treated subjects compared with untreated controls. The studies were completed in collaboration with the laboratory of Steven M. Rowe, M.D. at the University of Alabama at Birmingham and the data will be presented in a poster presentation at the North American Cystic Fibrosis Conference (NACFC), being held from October 27-29 in Orlando, Florida.

“SYGN303 is designed to reduce mucofecal obstruction and reduce inflammatory responses in the mucosal lining of the gastrointestinal tract. These data support our novel approach to treat this serious complication of CF,” said Shenda Baker, Ph.D., President and Chief Operating Officer of Synedgen. “The results of Dr. Rowe’s study provide clear rationale for the continued development of SYGN303 as a potential treatment for DIOS in patients with cystic fibrosis – a complication with no targeted or approved therapeutic options.”

Cystic fibrosis (CF) is a life-shortening genetic disorder that results in the accumulation of thick, sticky mucus in the lungs that clogs airways, leading to infection and chronic inflammation. The mucus also causes blockage and inflammation in the gastrointestinal (GI) tract, a complication known as distal intestinal obstructive syndrome (DIOS). Synedgen is developing a glycopolymer-based therapeutic, SYGN303, as a potential treatment for DIOS, for which there are currently no targeted or approved drugs.

Details of the presentation are as follows:

Session: Formal Poster Session – New Therapies, Biomarkers & Outcome Measures
Date: Thursday, October 27, 2016
Time: 11:15am EDT
Location: Hall C, Orange County Convention Center

Title: CFTR^-/- Rat with Distal Intestinal Obstructive Syndrome (DIOS)

In an in vivo preclinical model of cystic fibrosis, oral administration of Synedgen’s proprietary modified polysaccharide molecule once daily for 21 days prevented the development of DIOS and improved survival and growth as compared to untreated controls. In untreated subjects, increased bacterial load and prominent mucosal inflammation was observed.

In addition, preclinical data from Synedgen’s SYGN113 program being developed as an inhaled treatment to improve lung function in patients with cystic fibrosis will be presented. Details of the presentations are as follows:

Session: Formal Poster Session – Infection/Microbiology
Date: Thursday, October 27, 2016
Time: 11:15am EDT
Location: Hall C, Orange County Convention Center

Title: PAAG Removes Biofilms and Potentiates Antibacterial Activity Against Burkholderia cepacia Complex Clinical Isolates

Preclinical studies demonstrated that one-hour treatment of B. cepacia multi-drug resistant and/or mucoid phenotype clinical isolates with Synedgen’s proprietary modified polysaccharide molecule led to dose-dependent reductions in pre-formed complex biofilms. Upon treatment with Synedgen’s modified polysaccharide in combination with the antibiotic compounds tobramycin and meropenam, the proprietary molecule was found to potentiate antibacterial activity, reducing the concentrations necessary to kill bacteria into clinically safe concentrations.

Title: PAAG15A Removes Biofilms Against Nontuberculosis Mycobacteria Clinical Isolates

Preclinical studies demonstrated that treatment of Mycobacterium abscessus complex (MABSC) strains with Synedgen’s proprietary modified polysaccharide molecule once daily for ten minutes significantly reduced nontuberculosis mycobacteria (NTM) biofilms and, after 1-hour treatment, significantly reduced pre-formed NTM biofilms in a dose-dependent manner. The treated NTM biofilms were also found to have fewer live bacteria than untreated biofilms.

About SYGN303

SYGN303 is a glycopolymer-based therapeutic being developed as a potential treatment for distal intestinal obstructive syndrome (DIOS), a complication associated with cystic fibrosis in which thick mucus causes blockage in the intestine, for which there are currently no targeted or approved drugs. As a modified polysaccharide molecule, SYGN303 mimics the barrier function of the polysaccharide layer that lines the intestine to reduce the inflammatory response to damage, prevent further damage, and promote healing of the GI mucosal surface.

About Synedgen

Synedgen Inc. is a pioneering biotechnology company leveraging a unique proprietary glycomics technology platform to develop modified therapeutic polysaccharides that target mucosal surfaces in genetic and acquired disorders. Our programs are designed to meet unmet needs in treating inflammation, infection and mucosal damage and change the progression of disease to improve the quality of patients’ lives. www.synedgen.com

About the North American Cystic Fibrosis Conference

The North American Cystic Fibrosis Conference is sponsored by the Cystic Fibrosis Foundation and is the largest collaborative forum of its kind to advance research for the treatment and cure of CF. This annual meeting brings together scientists, clinicians and caregivers from around the world to discuss and share ideas on the latest advances in CF research, care and drug development and to exchange ideas about ways to improve the health and quality of life for people with CF. More than 4,000 researchers and health care professionals will attend the Meeting.

Media Contacts:
Casey R. Doucette, Ph.D.
MacDougall Biomedical Communications
781-235-3060
cdoucette@macbiocom.com

Preclinical Data to be Presented at North American Cystic Fibrosis Conference

Continue reading “Synedgen Reports Promising Data Demonstrating Biofilm Disruption and Potentiation of Antibacterial Activity in Burkholderia Clinical Isolates Treated with Glycopolymer-based Therapeutics” →

Top-line data on Moistagen for dry mouth demonstrates statistically significant outcomes.

Funding to support completion of clinical studies of multiple products, FDA device market clearance process and marketing efforts in support of the pending product launches.

Continue reading “Prisyna Secures $6M in Financing” →

Innovative Treatments to Improve GI & Lung Health and Antibiotic Effectiveness in CF Patients
Continue reading “Synedgen to Present New Treatment Options for CF complications at North American Cystic Fibrosis Conference” →

Recognized Industry Leader in Pharmaceutical Development

Continue reading “Synedgen Welcomes New Board Member Paul Grint” →

Treatment designed to reduce pain and inflammation associated with radiation therapy to the lower bowel

Continue reading “Synedgen Awarded National Cancer Institute Funding for Promising New Treatment for Medical Radiation-induced Bowel Injury” →

Synedgen Appoints Toxicology Specialists

Continue reading “Planning for Human Clinical Trials” →