Synthetic Biologics’ Statin-Class Candidate for Constipation-Predominant Irritable Bowel Syndrome Detailed at Company’s Investor Day

— Mark Pimentel, M.D., of Cedars-Sinai Delivered Keynote Presentation on Mechanism of Action —

ROCKVILLE, Md., Sept. 16, 2014 /PRNewswire/ — Synthetic Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing novel anti-infective biologic and drug programs targeting specific pathogens that cause serious infections and diseases, announced today the completion of the Company’s Investor Day in New York which highlighted its irritable bowel syndrome (IBS) program, including its novel, oral product SYN-010, targeting constipation-predominant IBS (C-IBS).

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In the keynote presentation, Mark Pimentel, MD, Director of the GI Motility Program and Laboratory at Cedars-Sinai Medical Center and Chairman of Synthetic Biologics’ C-IBS Clinical Advisory Board, described SYN-010 as belonging to the pharmaceutical class of statins, which  have  mainly been prescribed for managing cholesterol levels. SYN-010 is a proprietary modified release formulation of a classical statin that is optimal for reducing methane-production by certain microorganisms (Methanobrevibacter smithii) in the gut while avoiding systemic drug absorption. Methane produced by these organisms is perceived as the underlying cause of bloating, pain and constipation associated with C-IBS, and may contribute to the pathology of other diseases. SYN-010 is intended to treat the “core” cause of C-IBS, not just the symptoms.

Presentations at the Company’s event included an overview of the anticipated 505(b)(2) regulatory pathway for SYN-010 to reduce the impact of methane producing organisms on C-IBS and details on the extensive portfolio of granted use patents and pending applications for SYN-010 licensed by Cedars-Sinai to the Company.  Additional worldwide patent filings covering composition of matter claims, which were recently filed by Cedars-Sinai and licensed to the Company, could extend patent protection of SYN-010 to 2035.

Dr. Pimentel’s talk discussed his work that led to the discovery of SYN-010, including the association between the overproduction of methane gas by microorganisms in the gut and conditions such as C-IBS, and possibly other common morbidities such as obesity and Type-2 diabetes, as well as details on SYN-010’s molecular composition which classifies it as a statin.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases. The Company is developing an oral biologic to protect the gastrointestinal microflora from the effects of IV antibiotics for the prevention of Clostridium difficile (C. difficile) infection, an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS), a series of monoclonal antibodies for the treatment of Pertussis and Acinetobacter infections, and a biologic targeted at the prevention and treatment of a root cause of a subset of IBS. In addition, the Company is developing an 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

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, extension of patent protection to 2035 and intended impact of 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, our failure to initiate trials within the anticipated time frame, the ability to successfully and obtain desired results and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2013 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.

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SOURCE Synthetic Biologics, Inc.