Synthetic Biologics, Inc., a biotechnology company, announced that the US Patent & Trademark Office (USPTO) has issued US Patent No. 8,658,627 entitled, Pregnancy Hormone Combination for Treatment of Autoimmune Diseases, to the Regents of the University of California (UCLA).

The patent includes claims to the use of the company's drug candidate, Trimesta (oral estriol), in conjunction with a gestagen for the treatment of multiple sclerosis (MS) and other autoimmune diseases. The patent also includes a claim for the administration of Trimesta, a gestagen and a third standard of care MS agent, such as glatiramer acetate injection (Copaxone), interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia) or sphingosine-1-phosphate receptor modulator (Gilenya). Through its wholly owned subsidiary, Synthetic Biologics holds the exclusive license to the newly issued US Patent 8,658,627, as well as US Patents 8,372,826 and 6,936,599 and pending patents for MS and other autoimmune diseases covering the uses of its oral estriol candidate, Trimesta.

In an on-going randomized, double-blind, placebo-controlled phase II clinical trial for the treatment of women with relapsing-remitting MS, patients enrolled at 15 centres in the US are administered either Trimesta in combination with Copaxone and progesterone (a gestagen), or receive a placebo plus Copaxone. Lead Principal Investigator of the clinical trial, Rhonda Voskuhl,  Professor, Department of Neurology, Jack H Skirball Chair in Multiple Sclerosis Research and Director, Multiple Sclerosis Program at the UCLA School of Medicine, is scheduled to present topline results from this trial at the American Academy of Neurology's (AAN) 66th Annual Meeting in Philadelphia on April 29 & 30, 2014, as part of the AAN Emerging Science programme. 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.

"Claims in this new patent further expand Synthetic Biologics' intellectual property related to our oral estriol candidate, Trimesta, for the treatment of MS and other autoimmune diseases," stated Jeffrey Riley, chief executive officer at Synthetic Biologics. "Our objective has been to continue to strengthen our intellectual property covering oral estriol and this patent is an achievement in that direction."

Synthetic Biologics, Inc. is a biotechnology company focused on the development of anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and other diseases. The company is developing an oral treatment to reduce the impact of methane producing organisms on conditions such as constipation-predominant irritable bowel syndrome (C-IBS), 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 for the treatment of Pertussis and Acinetobacter infections, and a biologic targeted at the prevention and treatment of a root cause of IBS.