Biohaven Pharmaceutical Holding Company Ltd. a clinical-stage biopharmaceutical company developing novel treatments for neurological disorders, has 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.
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 (VAS). The observed reduction in anxiety was found to be significant. A likelihood-based analysis, that analysed 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’s glutamate modulating platform includes agents targeting glutamate transporters on glia and NMDA antagonism. Sublingual riluzole (BHV-0223) and the third generation prodrug troriluzole (BHV-4157) are being developed across a variety of neurologic and neuropsychiatric disorders. It is administered under the tongue, where it dissolves in seconds and does not require swallowing or administration with liquids.
Michael Bloch M.D., M.S., the trial’s Principal Investigator and an Associate Professor at Yale University School of Medicine, commented, “The findings from this anxiety-provoking challenge study in patients with social anxiety disorder demonstrated anti-anxiety effects of BHV-0223 in a public speaking scenario and suggest the therapeutic potential of glutamate modulation in the treatment of anxiety disorders.”
Vlad Coric M.D., CEO of Biohaven said, “Approximately 20% of Americans have experienced an anxiety disorder in the past year but many current treatments are encumbered by side effects including sedation, cognitive impairment and potential for addiction. By combining anxiolytic properties and a favourable safety profile, we believe that glutamate modulating agents may offer patients who are not satisfied with existing therapies a novel treatment option.”