— Company’s Irritable Bowel Syndrome with Constipation (IBS-C) Program to Reduce the Impact of Methane Gas in the Gut on Target to Initiate Phase 2 Clinical Trial in 2Q 2015 —
ROCKVILLE, Md., May 18, 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, announced that preclinical results supporting the development of SYN-010, the Company’s candidate therapy to reduce the impact of methane producing organisms on irritable bowel syndrome with constipation (IBS-C), were presented in a poster at Digestive Disease Week® (DDW) 2015 in Washington DC today. The research was sponsored by Synthetic Biologics and performed at Cedars-Sinai under the direction of Mark Pimentel, M.D., FRCP(C), Director of Cedars-Sinai’s GI Motility Program and Laboratory, and Chairman of Synthetic Biologics’ IBS-C Clinical Advisory Board.
The “Lovastatin Improves Stool Form in Methanobrevibacter smithii Colonized Rats with Constipation” poster summarized preclinical efficacy data that support advancing Synthetic Biologics’ novel SYN-010, toward the clinic. The poster presented key data from a rat model, which confirmed findings from previous studies conducted by Dr. Pimentel, with the following conclusions:
- Lovastatin reduced Methanobrevibacter smithii (M. smithii) levels in the ileum (but not other intestinal segments) of rats administered a high-fat diet; and
- Lovastatin improved stool water content in these rats.
“The data suggest that SYN-010 has therapeutic potential to diminish the production of methane in the gut, treating the cause of IBS-C, not just the symptoms,” said Dr. Mark Pimentel.
“The presentation at the DDW meeting highlighted the therapeutic potential of SYN-010 for IBS-C,” stated Jeffrey Riley, Chief Executive Officer for Synthetic Biologics. “This research, along with the fact that SYN-010 is a new modified-release formulation of a widely prescribed statin drug, provides a strong body of evidence as Synthetic Biologics seeks to move our IBS-C program into a Phase 2 clinical trial during the second quarter of this year, with topline results anticipated to follow during the second half of this year.”
Dr. Pimentel led the investigational team at Cedars-Sinai whose discoveries established the foundation of Synthetic Biologics’ IBS-C program. SYN-010 is a proprietary modified-release formulation of the classic statin, Lovastatin, that is optimal for reducing 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 bloating, pain and constipation associated with IBS-C, and may contribute to the pathology of other diseases. SYN-010 is intended to act primarily in the intestinal lumen while avoiding systemic absorption, thereby targeting the cause of IBS-C, not just the symptoms.
According to reports published by The International Foundation for Functional Gastrointestinal Disorders (IFFGD), IBS affects an estimated 10 to 15 percent of the population, or as many as 40 million Americans. The illness affects both men and women; however, two-thirds of diagnosed sufferers are women. The onset of IBS can begin anytime from adolescence to adulthood. It has been reported that up to one-third of all IBS patients have IBS-C. Current Food and Drug Administration (FDA)-approved therapies for the treatment of IBS-C include AMITIZA® (lubiprostone) and LINZESS® (linaclotide), and along with prescription and over-the-counter laxatives, provide patients with symptomatic relief and do not treat the underlying cause of bloating, pain and constipation associated with IBS-C.
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. An extensive 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 and an oral statin treatment to reduce the impact of methane producing organisms on irritable bowel syndrome with constipation (IBS-C). 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 Actavis, 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 therapeutic potential for SYN-010, intended treatment for SYN-010, the potential market for SYN 010,, anticipated timing of the Phase 2 clinical trial and topline results, and the anticipated 505(b)(2) regulatory pathway 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, the ability of SYN-010 to perform as expected 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.
Released May 18, 2015