— Company’s SYN-010 Program to Reduce the Impact of Methane Gas in the Gut Currently in Phase 2 Clinical Trials —
ROCKVILLE, Md., Oct. 20, 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 experimental results supporting the proposed therapeutic mode-of-action of SYN-010 in irritable bowel syndrome with constipation (IBS-C) were presented today in a poster at the American College of Gastroenterology (ACG) Annual Meeting in Honolulu, HI. 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 Medical Center’s (CSMC) GI Motility Program and Laboratory, and Chairman of Synthetic Biologics’ IBS-C Clinical Advisory Board.
“The presentation at the ACG Annual Meeting highlighted the therapeutic potential of SYN-010 for IBS-C,” stated Jeffrey Riley, Chief Executive Officer for Synthetic Biologics. “As we continue to move our IBS-C program through two ongoing Phase 2 clinical trials, this research, along with SYN-010’s novel modified-release formulation of the widely prescribed lovastatin lactone, provides a strong body of support for SYN-010’s efficacy in reducing methane levels in the gut. We continue to expect topline results from the first Phase 2 clinical trial of SYN-010 during the fourth quarter of 2015, and topline results from the second Phase 2 clinical trial during the first half of 2016.”
Synthetic Biologics’ proprietary SYN-010 is a modified-release formulation of the lactone form of 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, and published reports have associated higher intestinal methane production with increased constipation severity in IBS-C patients. 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.
The CSMC poster, entitled “Lovastatin Lactone Inhibits Methane Production in Human Stool Homogenates,” included data from studies comparing the effects of different statins and statin forms (lactone vs. beta-hydroxyacid) on methane production by stool homogenates from five female donors with high levels of breath methane. Dr. Pimentel concluded that, of the various statins examined, lovastatin lactone was the only effective inhibitor of methane production in the stool homogenates, significantly inhibiting methane levels by -65% compared to the control stool.
“This lovastatin data suggests that SYN-010 has therapeutic potential to diminish the production of methane in the gut, thereby treating the cause of IBS-C, not just the symptoms,” said Dr. Mark Pimentel.
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 CSMC to Synthetic Biomics, Inc., a subsidiary of Synthetic Biologics, Inc. CSMC also holds a minority equity interest in Synthetic Biomics.
About Irritable Bowel Syndrome with Constipation (IBS-C)
IBS is a functional gastrointestinal disorder that affects an estimated 10 to 15 percent of the population, or as many as 45 million people in North Americai. The illness affects both men and women; however, two-thirds of diagnosed sufferers are women. Current U.S. Food and Drug Administration (FDA)-approved therapies for the treatment of IBS-C and other treatments including prescription and over-the-counter laxatives, provide patients with temporary symptomatic relief, but do not treat the underlying cause of pain, bloating and constipation associated with IBS-C.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a microbiome-focused, clinical-stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company’s lead candidates in Phase 2 development include 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 SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat the 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 monoclonal antibody combination for the treatment of Pertussis and 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 therapeutic potential for SYN-010, intended treatment for SYN-010, the potential market for SYN 010, anticipated timing of the topline results from the first and second Phase 2 trials, 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.
i The International Foundation for Functional Gastrointestinal Disorders. http://www.aboutibs.org/.
Accessed June 19, 2015.
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SOURCE Synthetic Biologics, Inc.
Released October 20, 2015