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

Preclinical Data to be Presented at North American Cystic Fibrosis Conference

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 biofilm degradation and increased antibacterial activity in bacterial isolates from cystic fibrosis (CF) patients after treatment with a proprietary modified polysaccharide molecule. The data will be presented by Stacy Townsend, Ph.D., Vice President of Research at Synedgen, in poster presentations at the North American Cystic Fibrosis Conference (NACFC), being held from October 27-29 in Orlando, Florida.

“The data presented here demonstrate the promise of Synedgen’s glycopolymer-based biofilm-disrupting approach as a strategy for increasing bacterial sensitivity and decreasing resistance to antibiotics – which could result in more positive therapeutic outcomes in CF-related infections,” stated Steven M. Rowe, M.D., Professor of Pulmonary Medicine and Physiology & Biophysics at the University of Alabama at Birmingham.

“The anti-biofilm properties exhibited by our glycopolymer-based molecules in these preclinical studies expose biofilm-protected bacteria to antibiotics. Enabling antibiotics to reach and effectively neutralize their targets is a critical mechanism to combat infection and antibiotic resistance, which are serious and life-threatening complications for cystic fibrosis patients,” said Shenda Baker, Ph.D., President and Chief Operating Officer of Synedgen. “The data presented at NACFC continue to suggest that Synedgen’s therapeutic candidate, SYGN113, has the potential to become a novel addition to the armamentarium for treating pulmonary exacerbations and bacterial infections in cystic fibrosis. We look forward to initiating a Phase 1 clinical trial of SYGN113 in CF patients in 2017.”

Cystic fibrosis, a life-shortening genetic disorder that results in the accumulation of thick, sticky mucus in the lungs, is frequently associated with bacterial infection. Because of the inability to clear the airways, bacterial colonization and biofilm formation results. These biofilms are difficult for antibiotics to penetrate, and thus Synedgen is developing a new class of glycopolymer-based therapeutics that facilitate mucus expectoration and biofilm disruption, thereby rendering otherwise protected bacteria susceptible to antibiotics.

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.

In addition, data from the laboratory of Steven M. Rowe, M.D. evaluating Synedgen’s glycopolymer-based therapeutics for the treatment of distal intestinal obstructive syndrome (DIOS) in a preclinical model of cystic fibrosis will be presented. 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.

About SYGN113

SYGN113 is a glycopolymer-based therapeutic being developed as an inhaled treatment to improve lung function in patients with cystic fibrosis. As a modified polysaccharide molecule, SYGN113 interacts with native glycoproteins in mucus and polysaccharides in bacterial biofilms to reduce mucus viscosity and adhesion and break up biofilms, which are key drivers of pulmonary exacerbations and infections in cystic fibrosis patients.

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.


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 Contact:

Casey R. Doucette, Ph.D.
MacDougall Biomedical Communications