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Synthetic Biologics Inc announces topline Phase II study results of Trimesta


Wednesday, 30 Apr 2014 06:58am EDT 

Synthetic Biologics Inc:Detail topline Phase II study results of Trimesta (oral estriol), which the Company is developing as a once-daily adjunctive oral treatment for relapsing-remitting multiple sclerosis (RRMS) in women.In this Phase II study, women receiving oral Trimesta plus injectable Copaxone demonstrated a statistically significant 47 percent decrease in annualized MS relapse rate in first 12 months of treatment compared to women receiving placebo plus Copaxone (p=0.0306).Says 32 percent decrease in annualized relapse rate at 24 months (p=0.1527).Patients in both treatment arms demonstrated improved scores on the Expanded Disability Status Scale (EDSS) compared to baseline.Cognitive function test scores, as measured by the Paced Auditory Serial Addition Test (PASAT), in women receiving Trimesta plus Copaxone also improved compared to baseline and were significantly different from placebo plus Copaxone at 12 months.Treatment was generally safe and well tolerated.There were 21 serious adverse events (9 in the Trimesta plus Copaxone group and 12 in the placebo plus Copaxone group).Adverse events were typically mild in nature and balanced between treatment groups except for an increase in irregular menses in patients who received Trimesta. 

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