ROCKVILLE, Md., Dec. 7, 2013 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of product candidates focused on the prevention and treatment of serious infectious diseases and other diseases, announced today that it entered into worldwide license and option agreements with Cedars-Sinai Medical Center ("Cedars-Sinai") for the development of new treatment approaches to target non-bacterial intestinal microorganism life forms known as archaea that are associated with intestinal methane production and chronic diseases such as irritable bowel syndrome (IBS), obesity and type 2 diabetes, through its newly formed subsidiary, Synthetic Biomics, Inc.
Cedars-Sinai investigators have discovered that eradicating archaea and inhibiting intestinal methane production may treat the underlying cause of major diseases not typically considered forms of infectious diseases. IBS, one of the most prevalent chronic diseases, affects approximately 40 million Americans (an estimated 16 million of which have the archaea-associated constipation-predominant form of the disease (C-IBS)). Obesity affects over one-third (35.7%) of adult Americans according to the Centers for Disease Control (CDC). Diabetes affects an estimated 25.8 million Americans according to the CDC.
Ongoing efforts include formulating and clinically testing non-antibiotic FDA-approved oral drug candidates for ultimate product registration via potential expedited pathways. Such candidates are intended for the specific eradication of gastrointestinal archaea and prevention of their recolonization, with the goal of having little or no impact on a patient's normal bacterial microflora. These efforts are being led by Mark Pimentel, M.D., FRCP(C), Director of the Gastrointestinal Motility Program at Cedars-Sinai Medical Center, who is credited with discovering that IBS is a form of infectious disease, in which gut microflora that should normally be confined to the large intestine inappropriately colonize the small intestine. This process is referred to as small intestinal bacterial overgrowth (SIBO), which results in gas, bloating, abdominal pain and altered stool habits characterized by IBS. The Company licensed and optioned from Cedars-Sinai a portfolio of intellectual property comprised of several U.S. and international patents and pending patent applications for various fields of use, including C-IBS, obesity and diabetes."We are pleased to initiate this exciting new anti-infective approach to treat these major archaea-implicated disease indications with Cedars-Sinai along with Dr. Pimentel's leadership," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics, Inc. "This program complements our current microbiome focus and expertise, which includes development of an oral biologic to protect the microbiome from the effects of hospital administered IV antibiotics for the prevention of C. diff infection." Dr. Pimentel stated, "Since uncovering the fundamental role that small intestinal bacterial overgrowth plays in IBS, our group has continued to uncover and increasingly appreciate the role that intestinal archaea play in highly prevalent diseases areas including, C-IBS, obesity, and type 2 diabetes. I am excited to be working with Synthetic Biologics and its newly formed subsidiary, Synthetic Biomics, to develop potential breakthrough pathogen-specific approaches for these major disease indications."