Synedgen Announces Presentation of Data at NACFC Demonstrating Prevention of Gastrointestinal Complications with Glycopolymer-Based Therapeutics in a Preclinical Model of Cystic Fibrosis

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