— Oral Presentation to Include Greater Detail on Clinical Outcomes, Including Significant and Unique Improvements in Cognition —
ROCKVILLE, Md., July 31, 2014 /PRNewswire/ — Synthetic Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced today that Rhonda Voskuhl, M.D., the lead investigator of the Phase II clinical trial evaluating Trimesta™, the Company’s oral product candidate for the treatment of relapsing-remitting multiple sclerosis (MS), is scheduled to present additional clinical outcome data, including more detailed results on cognitive and disability measures. The data will be presented at the 2014 Joint Americas and European Committees for Treatment and Research in Multiple Sclerosis Meeting (ACTRIMS-ECTRIMS) in Boston.
The abstract titled, A Combination Trial of Estriol Plus Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis: Effects on Disabilities, will be featured in an oral presentation on Friday, September 12, 2014, at 8:39am (ET).
“We are thrilled that Dr. Voskuhl will present additional clinical findings for Trimesta, an oral agent for treating MS in women. The presentation provides further data on the Phase II topline efficacy results reported in April 2014, comparing Trimesta in combination with Copaxone® to Copaxone® alone as an active control arm. The presentation is expected to provide details about the significant clinical outcome measures including relapse rate, disability, and cognition measures evaluated in this compelling trial,” stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “If the findings are supported in further studies, Trimesta, either alone or in combination with other MS drugs, could become a leading front-line therapy for women with MS due to its unique and differentiated anti-inflammatory, as well as neuroprotective benefits.”
Dr. Voskuhl commented, “The clinically significant improvement in cognitive testing in women taking Trimesta in this Phase II study is of high importance for MS specialists and patients. We believe the differentiated mechanism of action observed with Trimesta presents a new oral opportunity and has the potential to be an ideal added oral therapy to address significant unmet needs for women affected by this progressive, debilitating condition.”
Trimesta™ (oral estriol) is Synthetic Biologics’ investigational drug being evaluated in combination with Copaxone® (glatiramer acetate injection) in an investigator-initiated, 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 15 other U.S. centers, administered either Trimesta (8 milligrams orally per day) plus Copaxone® (20 milligrams per day), or placebo plus Copaxone® to patients randomized in the trial. This investigator-initiated 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 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.
Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.
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 benefits of Trimesta for patients with MS, the ability of Trimesta either alone or in combination with other MS drugs, could become a leading front-line therapy for women and the belief that Trimesta presents a new oral opportunity and has potential to be an ideal added therapy to address significant unmet needs for women with MS. 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 additional clinical 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, 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.
[i] Credit Suisse. Multiple Sclerosis-Evolution or Revolution Report. March 18, 2013.
SOURCE Synthetic Biologics, Inc.
Released July 31, 2014