— Company’s License Covers C-IBS, Type 2 Diabetes and Obesity —
ROCKVILLE, Md., June 25, 2014 /PRNewswire/ — Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, today announced that researchers at Cedars-Sinai Medical Center (Cedars-Sinai) found that eradication of breath methane and reduction of intestinal levels of the most common methanogenic bacterium in the human gut (M. smithii) resulted in improved insulin sensitivity by up to 50 percent, and a reduction in total cholesterol and LDL cholesterol levels in pre-diabetic, obese human subjects. The findings provide preliminary evidence that the management of methane in the gut may lead to a new generation of medicines for treating Type 2 diabetes and obesity, two morbidities often linked together.
This Cedars-Sinai study, which was funded by the American Diabetes Association (ADA), was the subject of a late breaking poster presentation at the ADA’s 74th Scientific Sessions recently held in San Francisco. This research examined the effects of methane-regulating treatments on conditions such as Type 2 diabetes and obesity, which along with constipation-predominant irritable bowel syndrome (C-IBS), are the three conditions for which Synthetic Biologics has the right to develop treatments under the exclusive license agreement with Cedars-Sinai dated December 5, 2013. The most clinically advanced of Synthetic Biologics’ programs in this area is the development of SYN-010, an oral treatment to reduce the impact of methane producing organisms on C-IBS, with a Phase II trial expected to start during the second half of 2014.
In the poster presented at ADA, lead researcher Ruchi Mathur, M.D., FRCP(C) of Cedars-Sinai, along with other Cedars-Sinai researchers, including Mark Pimentel, M.D., FRCP(C), reported that eradication of M. smithii (as measured by the surrogate of breath methane) in 8 of the 11 pre-diabetic, obese subjects tested resulted in improvement in the subjects’ metabolic profiles after a 10 day course of antibiotics.
“Cedars-Sinai researchers have previously shown that the presence of methane in the gut is associated with a slowing of intestinal transit, which may also allow for increased time for absorption of nutrients and enhanced energy harvest thus contributing to a variety of diseases including C-IBS, diabetes and obesity,” noted Jeffrey Riley, Chief Executive Officer of Synthetic Biologics.
Mr. Riley concluded, “The results from this new research provide further exciting insight into the role of gut methane in various metabolic diseases, including Type 2 diabetes and obesity. These findings also support Synthetic Biologics’ efforts to develop new therapeutic agents, such as SYN-010, to manage the chronic symptoms of C-IBS through gut methane depletion.”
About SYN-010 Clinical Development
In December 2013, Synthetic Biologics entered into worldwide exclusive license and option agreements with Cedars-Sinai for the development of products for therapeutic and prophylactic treatments for acute and chronic diseases, such as C-IBS, Type 2 diabetes and obesity. Synthetic Biologics will focus initially on the development of SYN-010, an oral treatment to reduce the impact of methane producing organisms on C-IBS. The Company initiated in vivo/pharmacokinetic/pharmacodynamic studies in the first half of 2014, and expects to initiate a Phase II clinical trial during the second half of 2014 under an Investigational New Drug (IND) application.
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 www.therivabio.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 Synthetic Biologics’ intended development efforts and the effects of the management of methane on Type 2 Diabetes and obesity. 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, studies and those conducted by investigators, to be commenced or completed on time or to achieve desired results or results similar to those in the findings from the research project, a failure of Synthetic Biologics’ clinical trials to receive anticipated funding, a failure of Synthetic Biologics’ candidates for the prevention and treatment of infectious 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, 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.
SOURCE Synthetic Biologics, Inc.
Released June 25, 2014