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Synthetic Biologics Announces Issuance of First Key U.S. Patent Directly Covering SYN-010, the Company's Novel Candidate for Irritable Bowel Syndrome with Constipation (IBS-C)
Date:11/24/2015

ROCKVILLE, Md., Nov. 24, 2015 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases, announced today that the U.S. Patent and Trademark Office has issued a patent that covers use of a range of compounds, including the active agent of SYN-010, for the treatment of irritable bowel syndrome with constipation (IBS-C). This is Synthetic Biologics' first issued U.S. patent directly pertaining to SYN-010 and adds to the Company's extensive IBS-C patent estate.

U.S. Patent No. 9,192,618, issued on November 24, 2015, includes claims that cover Synthetic Biologics' clinical SYN-010 IBS-C program. This patent, which is exclusively licensed from Cedars-Sinai Medical Center (CSMC), is the result of research directed by Mark Pimentel, M.D., FRCP(C), Director of CSMC's GI Motility Program and Laboratory and Chairman of Synthetic Biologics' IBS-C Clinical Advisory Board. This new U.S. patent enlarges Synthetic Biologics' SYN-010-related patent estate; patents from the same family have been granted in Europe, Canada and Australia. Additional worldwide patent filings, co-owned by CSMC and Synthetic Biologics and licensed to the Company, include composition of matter claims that could extend patent protection of SYN-010 to 2035.

SYN-010 is Synthetic Biologics' proprietary, modified-release formulation of lovastatin lactone that is intended to reduce methane production by certain microorganisms (M. smithii) in the gut while minimizing disruption to the microbiome. SYN-010 is intended to act primarily in the intestinal lumen, ideally limiting systemic absorption, thereby targeting a major cause of IBS-C, not just the symptoms. Synthetic Biologics anticipates a 505(b)(2) regulatory pathway for SYN-010.

"This new patent will strengthen the protection of SYN-010 in the U.S. and complements existing foreign patents," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "We continue to bolster the Company's patent estate while making progress toward our goals to report Phase 2 topline results from both our IBS-C and prevention of C. difficile infection programs this quarter."

Synthetic Biologics' Microbiome Clinical Program Seminar in NYC

As previously announced, Synthetic Biologics is hosting a Microbiome Clinical Program Seminar on Thursday, December 10, 2015, from 9:00 – 11:30 a.m. EST in New York City. Clinical updates will be provided on Synthetic Biologics' gut microbiome candidates – SYN-010 for the treatment of IBS-C and SYN-004 for the prevention of C. difficile infection and antibiotic-associated diarrhea. Space is limited, and attendance is by invitation only. A live webcast will be available at www.syntheticbiologics.com, and an archived replay will be available following the event.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company's lead candidates in Phase 2 development include: (1) SYN-004 which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD), and (2) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and in collaboration with Intrexon Corporation (XON), a preclinical stage monoclonal antibody for the prevention and treatment of Pertussis and discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.

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 continued bolstering of the patent estate, the goal of reporting Phase 2 topline results from both the IBS-C and prevention of C. difficile infection programs this quarter, the extension of the patent protection of SYN-010 until 2035, and the intended potential of SYN-010 to reduce methane production and target a cause of IBS-C. 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.

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SOURCE Synthetic Biologics, Inc.
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