Synthetic Biologics’ Initiates SYN-010 Phase 2 Clinical Trial to Treat Irritable Bowel Syndrome with Constipation (IBS-C)

ROCKVILLE, Md., June 29, 2015 /PRNewswire/ — 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[i]. 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.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company is developing an oral biologic to protect the gut microbiome from intravenous (IV) antibiotics for the prevention of C. difficile infection [two Phase 2a studies ongoing] and an oral statin treatment to reduce the impact of methane producing organisms on irritable bowel syndrome with constipation (IBS-C) [Phase 2 study ongoing]. In addition, the Company is developing a monoclonal antibody combination for the treatment of Pertussis in collaboration with Intrexon Corporation (NYSE: XON), and a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS. For more information, please visit Synthetic Biologics’ website at www.therivabio.com.

AMITIZA^® is a registered trademark of Sucampo AG, and used under license by Takeda Pharmaceuticals America, Inc.
LINZESS^® is a registered trademark of Ironwood Pharmaceuticals, Inc.

This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the potential of SYN-010 to reduce methane production for the treatment of IBS-C and address an unmet need, the anticipated timing of the reporting of topline data from the initial Phase 2 clinical trial and the timing of initiation of a second Phase 2 clinical trial and the potential market for SYN-010. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics’ therapeutics, a failure of Synthetic Biologics’ clinical trials, and those conducted by investigators, to be commenced or completed on time or to achieve desired results, a failure of Synthetic Biologics’ clinical trials to receive anticipated funding, a failure of Synthetic Biologics’ products for the prevention and treatment of diseases to be successfully developed or commercialized, Synthetic Biologics’ inability to maintain its licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2014 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

[i] The International Foundation for Functional Gastrointestinal Disorders. http://www.aboutibs.org/. Accessed June 19, 2015.

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SOURCE Synthetic Biologics, Inc.