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Synthetic Biologics Reports Positive Topline Data from Second Phase 2 Clinical Trial of SYN-010 in Patients with Irritable Bowel Syndrome with Constipation (IBS-C)
Date:1/19/2016

ROCKVILLE, Md., Jan. 19, 2016 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused on developing therapeutics to protect the gut microbiome, reported that the second Phase 2 clinical trial of its proprietary SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C) met its primary endpoint.

Topline data from all patients who completed the second Phase 2 clinical trial of SYN-010 showed a statistically significant decrease in methane production (p=0.002) from the beginning of the first Phase 2 study (Study 1 baseline - Day 1) to the end of the second Phase 2 study (12 weeks of treatment - Day 84), thus meeting the study's primary endpoint. There were no serious adverse events observed.

Topline data from the second Phase 2 study also showed improvements in secondary efficacy endpoints, including:

  • A statistically significant reduction in the mean IBS Symptom Severity Score (IBS-SSS; p<0.0001), which includes abdominal pain, bloating, stool frequency and quality of life scores, for all patients from Study 1 baseline to the end of the second Phase 2 study.
  • An increase in the percentage of patients identified as Monthly Responders, an FDA-defined composite measure incorporating improvements in complete spontaneous bowel movements (CSBMs) and abdominal pain.1

"These topline data demonstrate the positive effect of SYN-010 on decreasing gut methane production, abdominal pain and bloating, and improving stool frequency and quality of life scores in IBS-C patients who are breath-methane positive," said Dr. Pimentel, Director of the GI Motility Program and Laboratory at Cedars-Sinai, and Chairman of Synthetic Biologics' IBS-C Clinical Advisory Board. "Current IBS-C treatments are focused on relieving symptoms. These latest SYN-010 findings, along with previously reported topline data, strongly suggest a potential role for SYN-010 in treating a major underlying cause of IBS-C by reducing the production of methane in the gut, versus relieving symptoms."

This second Phase 2, open-label SYN-010 clinical trial was conducted for eight weeks at multiple centers in the United States. The primary endpoint of this extension study was to evaluate the sustainability of the effect of one daily dose strength (42 mg) of SYN-010 on breath methane production in breath methane-positive patients with IBS-C. Secondary endpoints included evaluation of the reduction in abdominal pain and bloating, the improvement in stool frequency and overall quality of life. Fifty-four patients, who completed the first Phase 2 clinical trial of SYN-010 (a four-week study of patients randomly assigned to receive placebo, a 21 mg SYN-010 dose or a 42 mg SYN-010 dose once daily), rolled over into the second Phase 2 clinical trial of SYN-010.

"Meeting the study endpoints and demonstrating positive clinical outcomes in this Phase 2 trial of SYN-010 bring us closer to offering a therapeutic to the millions of people who suffer from IBS-C," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "During the first half of 2016, we anticipate reporting detailed results from this Phase 2 clinical trial and requesting an end of Phase 2 meeting with the FDA. Concurrent with the analysis of the Phase 2 data, we are actively planning the Phase 3 program for SYN-010."

Conference Call

Synthetic Biologics' management will host a conference call tomorrow, Wednesday, Jan. 20, 2016, at 8:30 a.m. (ET), along with featured guest speaker, Mark Pimentel, MD, FRCP(C), Director of the GI Motility Program and Laboratory at Cedars-Sinai, and Chairman of Synthetic Biologics' IBS-C Clinical Advisory Board. The dial-in information for the call is as follows: U.S. toll free: 1-888-347-5280 and International: +1 412-902-4280.

Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at https://www.webcaster4.com/Webcast/Page/1096/12885. An archive of the call will be available for approximately 90 days at the same URL https://www.webcaster4.com/Webcast/Page/1096/12885 beginning approximately one hour after the call's conclusion.

About SYN-010

SYN-010 is a 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 to treat an underlying cause of IBS-C. SYN-010 is intended to act primarily in the intestinal lumen while avoiding systemic absorption, thereby targeting a 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.

About Synthetic Biologics' Breath Methane Publication in Alimentary Pharmacology & Therapeutics

Synthetic Biologics' peer-reviewed article titled "Inhibition of Methanogenic Archaea by Statins as a Targeted Management Strategy for Constipation and Related Disorders", evaluating the therapeutic potential and mechanism of action of certain statins in inhibiting the production of methane was recently published in the journal Alimentary Pharmacology & Therapeutics. The article describes observational and experimental studies which show a strong correlation between the production of methane by the dominant methane-producing microorganism in the gut, M. smithii, and slowed stool transit in the intestines commonly seen in patients with IBS-C. To access the online publication, please use the following link: http://onlinelibrary.wiley.com/doi/10.1111/apt.13469/epdf.

About Irritable Bowel Syndrome

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 and current FDA-approved therapies for the treatment of IBS-C, which include prescription and over-the-counter laxatives, do little to treat the underlying cause of the disease. These products provide patients with temporary relief from the symptoms of constipation by elevating the amount of water which passes through the gastrointestinal tract, but tend to cause an IBS-C patient to swing from suffering from constipation, to suffering from diarrhea.

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 (NYSE: 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 potential of SYN-010 to reduce methane production for the treatment of IBS-C, the ability of SYN-010 to protect the microbiome, the size of the market, the anticipated timing of the reporting of detailed results from the Phase 2 trial and an end of Phase 2 meeting with the FDA, and initiating a Phase 3 clinical trial 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, 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.

1 A Monthly Responder is defined as a patient who has a Weekly Response in at least 50% of the weeks of treatment during the month. A Weekly Responder is defined as a patient who experiences a decrease in weekly average score for worst abdominal pain in the past 24 hours of at least 30% compared with Study 1 Baseline and a stool frequency increase of 1 or more CSBM per week compared with Study 1 Baseline.

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