ROCKVILLE, Md., Feb. 10, 2014 /PRNewswire/ — Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of product candidates focused on the prevention and treatment of serious infectious and other diseases, announced today that Rhonda Voskuhl, M.D., the lead investigator of the Phase II clinical trial evaluating the Company’s oral estriol product candidate, Trimesta™, for the treatment of relapsing-remitting multiple sclerosis (MS), will present topline results at the American Academy of Neurology’s (AAN) 66th Annual Meeting in Philadelphia. The abstract titled, A Combination Trial of Estriol Plus Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis, will be presented as part of the AAN Emerging Science program during two sessions, as follows:
MS and CNS Inflammatory Disease: Novel Therapeutics
Presentation: 003
Event Date: Tuesday, April 29, 2014
Presentation Time: 3:45 p.m. (ET)
Emerging Therapeutic Advances in Multiple Sclerosis
Presentation: 002
Event Date: Wednesday, April 30, 2014
Presentation Time: 5:35 p.m. (ET)
Trimesta™ (oral estriol) is being evaluated in combination with Copaxone® (glatiramer acetate injection) in a randomized, double-blind, placebo-controlled Phase II clinical trial for the treatment of relapsing-remitting MS in women. Lead Principal investigator, Rhonda Voskuhl, M.D., Professor, Department of Neurology, Jack H. Skirball Chair in Multiple Sclerosis Research and Director, Multiple Sclerosis Program at University of California, Los Angeles (UCLA) School of Medicine, along with investigators at 14 other U.S. centers, administered either Trimesta™ (8 milligrams orally per day) in combination with Copaxone® (20 milligrams per day), or a placebo plus Copaxone® to patients randomized in the trial.
Patients in this Phase II relapsing-remitting MS trial completed their final 24-month visit during January 2014. The primary outcome measure for the study is the annualized rate of relapse between the placebo and treated groups, an accepted FDA-approvable endpoint in MS. The clinical trial is supported by grants exceeding $8 million, awarded primarily by the National Multiple Sclerosis Society (NMSS) in partnership with the NMSS’s Southern California chapter, and the National Institutes of Health.
About Multiple Sclerosis
MS is a progressive neurological disease in which the body loses the ability to transmit messages along central nervous system nerve cells, leading to pain, loss of muscle control, paralysis, cognitive impairment and in some cases death. According to the NMSS, more than 2.3 million people worldwide (approximately 400,000 patients in the U.S., of which approximately 65% are women) have been diagnosed with MS. The diagnosis is typically made in young adults, ages 20 to 50. According to the NMSS, approximately 85% of MS patients are initially diagnosed with the relapsing-remitting form, and 10-15% with other progressive forms. Annual worldwide sales of current MS therapies are estimated at $14.1 billion.[i]
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of product candidates for serious infectious and other diseases. Synthetic Biologics is developing oral treatments targeting archaea, a non-bacterial intestinal form of life increasingly associated with chronic diseases such as irritable bowel syndrome (IBS), obesity and type 2 diabetes, an oral biologic to protect the gastrointestinal microflora from the effects of IV antibiotics for the prevention of C. diff infection, a series of monoclonal antibodies (mAbs) for the treatment of Pertussis and Acinetobacter infections, and a biologic targeted at the prevention and treatment of IBS. In addition, the Company is developing an oral estriol drug candidate 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 the expected impact of the trial results. 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 announced results of the trial not meeting our expectations and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2012 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] Credit Suisse. Multiple Sclerosis-Evolution or Revolution Report. March 18, 2013.
SOURCE Synthetic Biologics, Inc.
Released February 10, 2014