Biohaven: Anxiety med trial met primary endpoint

Biohaven Pharmaceutical announced positive results from a double-blind, placebo-controlled, proof of concept clinical trial evaluating the effect of BHV-0223 in patients diagnosed with social anxiety disorder and public speaking anxiety while performing an anxiety-provoking speech task. BHV-0223 met its primary endpoint of improvement in anxiety compared to placebo during an anxiety-provoking speech task in patients diagnosed with social anxiety disorder and public speaking anxiety. The investigator-initiated trial was performed at Yale University School of Medicine and treated 21 subjects who had a diagnosis of social anxiety disorder and participated in an anxiety-provoking, speech task in a double-blind, crossover design. In the pre-specified, primary analysis, BHV-0223 reduced anxiety by 8.3 points relative to placebo on the 100-point Visual Analogue Scale, or VAS. The observed reduction in anxiety was significant, relative to the protocol specified level. A likelihood-based analysis, that analyzed the change in the VAS from the pre-speech baseline, found that BHV-0223 had a 14.4-point advantage relative to placebo. In addition, BHV-0223 was safe and well-tolerated during this study. Biohaven expects to present additional results from this trial at upcoming scientific meetings over the next year. Based upon these trial results, Biohaven plans to expand its glutamate modulating platform development program to include the treatment of GAD. The trial results support further development of Biohaven’s glutamate modulating platform as a potential novel treatment for anxiety disorders. Biohaven has an exclusive license agreement with Yale University under Yale’s patent rights for the commercial development, manufacture, distribution, use and sale of products and methods related to the use of riluzole in treating a variety of central nervous system disorders including generalized anxiety disorder, social anxiety disorder and panic disorder. In addition to BHV-0223, Biohaven also owns worldwide patents and patent applications covering a broad library of prodrugs of riluzole designed for optimized safety, tolerability and pharmacokinetics.

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