Synthetic Biologics announces initiation of SYN-010 Phase 2 clinical trial for treatment of IBS-C

Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, reported the initiation of a Phase 2 clinical trial of its proprietary SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C). This is a placebo-controlled study to evaluate the ability of two dose strengths of SYN-010 to reduce the production of methane in breath methane-positive patients with IBS-C. Breath methane is strongly associated with constipation in IBS-C and higher methane levels are proportional to constipation severity.

IBS affects an estimated 10 to 15 percent of the population, or as many as 45 million people in North America. The illness affects both men and women; however, two-thirds of diagnosed sufferers are women. It has been reported that up to 20 percent of all IBS patients have IBS-C. Current U.S. Food and Drug Administration (FDA)-approved therapies for the treatment of IBS-C include AMITIZA^® (lubiprostone) and LINZESS^® (linaclotide), and prescription and over-the-counter laxatives. These products provide patients with temporary symptomatic relief, but do not treat the underlying cause of pain, bloating and constipation associated with IBS-C.

SYN-010 is a proprietary, modified-release formulation of the classic statin, lovastatin, that is intended to reduce methane production by certain microorganisms (M. smithii) in the gut while minimizing disruption to the microbiome. Methane produced by M. smithii is perceived as the underlying cause of pain, bloating, and constipation associated with IBS-C. SYN-010 is intended to act primarily in the intestinal lumen while avoiding systemic absorption, thereby targeting the major cause of IBS-C, not just the symptoms. To access the SYN-010 mechanism of action video on Synthetic Biologics' website, please click here.

"Initiating this Phase 2 clinical trial is an important first step to moving Synthetic Biologics' IBS-C program through the clinic," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "Patients who complete this first Phase 2 clinical trial of SYN-010, may enroll in a second, SYN-010 only, Phase 2 extension clinical trial that will evaluate the ability of SYN-010 to sustain the reduction in breath methane levels. We anticipate initiating the second Phase 2 trial and reporting topline results from the first Phase 2 clinical trial during the second half of 2015."

This Phase 2, randomized, double-blind, parallel-group, placebo-controlled, multi-dose study is expected to be conducted at multiple centers in the United States. The primary objective of this study is to evaluate the change from baseline in breath methane, as determined by a lactulose breath test, in methane-positive patients with IBS-C after seven days of treatment with one of two formulations of SYN-010 compared with placebo. Approximately 60 patients will be enrolled and randomly assigned in a 1:1:1 ratio to one of three groups, including two different SYN-010 dose groups and a placebo group. Patients are scheduled to receive single oral doses of SYN-010 each day for 28 days.

Mark Pimentel, M.D., FRCP(C), Director of the GI Motility Program and Laboratory at Cedars-Sinai, and lead investigator of the team whose pioneering discoveries established the foundation of Synthetic Biologics' IBS-C program, stated "With up to 9 million people suffering from IBS-C in the U.S., the development of SYN-010 has an opportunity to address a significant unmet medical need. Current treatments are focused on relieving symptoms, whereas SYN-010 has therapeutic potential to diminish the production of methane in the gut, treating a major cause of IBS-C, not just the symptoms."

Synthetic Biologics anticipates a 505(b)(2) regulatory pathway for SYN-010 which is designed to reduce the impact of methane producing organisms on IBS-C. A portfolio of granted use patents and pending applications for SYN-010 has been licensed by Cedars-Sinai to the Company. Additional worldwide patent filings covering composition of matter claims, which were filed by Cedars-Sinai in 2014 and licensed to Synthetic Biologics, could extend patent protection of SYN-010 to 2035.