Biohaven Pharmaceutical has reported positive results from a proof of concept clinical trial investigating the effect of BHV-0223 to treat patients with social anxiety disorder, after meeting the primary endpoint of the trial in a primary analysis.
The double-blind, placebo-controlled, crossover-assigned, investigator-initiated trial enrolled 21 patients at Yale University School of Medicine in the US.
The trial’s primary objective was to analyse the acute anti-anxiety potential of BHV-0223 against placebo in the enrolled patients diagnosed with social anxiety disorder and public speaking anxiety while performing a ten-minute anxiety-provoking speech task.
Results of the pre-specified primary analysis of the trial showed that 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 reportedly relative to the protocol specified level of p=0.10.
In addition, the trial includes a likelihood-based analysis, which evaluated the change in VAS from the pre-speech baseline, found that BHV-0223 had a 14.4-point advantage relative to placebo (p=0.0259).
BHV-0223 was also found to be safe and well-tolerated during the trial.
Biohaven CEO Vlad Coric 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.”
Based on the latest results, Biohaven intends to expand its glutamate modulating platform development programme for the treatment of generalised anxiety disorder (GAD), which is characterised by excessive anxiety, uncontrollable worry, restlessness and fatigue, among others.