Synthetic Biologics Issues UCLA Report of Prelim. Positive Topline Efficacy, Safety Results from Phase II Study of Trimesta
Synthetic Biologics, Inc. (NYSE: SYN), a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, reported today that the University of California, Los Angeles (UCLA) School of Medicine announced preliminary, positive topline data from the Phase II clinical trial evaluating Trimesta™ (oral estriol), the Company's oral, once-daily treatment for relapsing-remitting multiple sclerosis (RRMS) in women. The Phase II study, initiated and led by Rhonda Voskuhl, M.D., Professor, Department of Neurology, Jack H. Skirball Chair in Multiple Sclerosis Research and Director, Multiple Sclerosis Program at UCLA David Geffen School of Medicine, demonstrated that Trimesta given with first-line RRMS therapy Copaxone® (glatiramer acetate injection) resulted in reduced annualized relapse rate and improved cognitive function at 12 months of treatment as compared to placebo plus Copaxone. Dr. Voskuhl presented the Phase II topline data today at the 66^th Annual Meeting of the American Academy of Neurology in Philadelphia as part of the Emerging Science Program.
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Dr. Voskuhl commented, "Pregnancy is known to be a period of relative protection from MS relapses, and the therapeutic effects of pregnancy hormones, including estriol, include both anti-inflammatory and neuroprotective mechanisms as evidenced in animal models of MS. We are encouraged by the topline results from this first randomized placebo-controlled trial evaluating oral estriol due to the positive impact of adjunctive therapy with estriol on the patients in this study. We look forward to continued clinical evaluation of estriol, which we believe has the potential to slow disease progression and improve quality of life for women with RRMS."
The Phase II, double-blinded, placebo-controlled trial randomized 158 women with relapsing-remitting MS at 16 sites across the U.S. Among topline results, women receiving Trimesta plus Copaxone demonstrated a statistically significant 47 percent decrease in annualized MS relapse rate in the first 12 months of treatment as compared to women receiving placebo plus Copaxone. In addition, a significant improvement in cognitive function was observed at 12 months as measured by Paced Auditory Serial Addition Test (PASAT) scores. After 24 months of treatment, the reduction in relapse rate persisted in favor of the Trimesta plus Copaxone treatment group compared to the Copaxone plus placebo group (32 percent). Both treatment groups exhibited improvement in measures of cognitive function at 24 months. Treatment was safe and well tolerated with no evidence of adverse effects on breast or uterus.
"The topline data presented today are encouraging for women with MS, including the approximately 260,000 women with MS in the United States. We believe adjunctive therapy with Trimesta has the potential to improve therapeutic outcomes for women currently taking first-line RRMS treatments. Trimesta's differentiated mechanism of action, combined with the convenience of once-daily oral dosing, may potentially make it an ideal added therapy to address this underserved $14.1 billion worldwide market," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "As Synthetic Biologics determines next steps for Trimesta, including potential plans for a Phase III clinical program, we look forward to feedback from the neurology community and from potential partners regarding the encouraging topline data presented by Dr. Voskuhl."
The investigator-initiated, Phase II, two-year, multi-center, randomized, double-blinded, placebo-controlled (1:1) study evaluated Trimesta as an oral, once-daily dose of 8 mg per day plus Copaxone in women with RRMS, aged 18-50 years. Dr. Voskuhl's work is supported by grants exceeding $8 million, which were awarded primarily by the National Multiple Sclerosis Society (NMSS) in partnership with the NMSS's Southern California chapter, and the National Institutes of Health (NIH).
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