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news.Synthetic Biologics has concluded patient enrollment in its Phase II clinical trial of Trimesta (oral estriol), used for the treatment of relapsing-remitting multiple sclerosis (MS) in women.
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The randomized double-blind placebo-controlled multi-center Phase II clinical trial enrolled a total of 164 patients to investigate the efficacy and safety of Trimesta.
Synthetic Biologics chief executive officer Jeffrey Riley said as an oral therapy with a promising clinical profile, Trimesta is expected to provide an important treatment option for MS.
The primary objective of the study is the rate of relapse between the placebo and treated groups at two years, an accepted FDA-approvable endpoint in MS.
University of California, Los Angeles multiple sclerosis program director Rhonda Voskuhl said with this trial evaluating oral estriol, they expect to demonstrate a reduction in the rate of relapses in these MS patients.