Phase III trial of troriluzole fails to meet endpoint in generalized anxiety disorder.- Biohaven Pharma
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Published:11th Feb 2020
Biohaven Pharmaceutical reported negative topline results from its Phase III clinical trial evaluating troriluzole compared to placebo for the treatment of patients with Generalized Anxiety Disorder (GAD). This eight-week trial randomized 402 adult patients equally at more than 45 centers in the United States. In this trial, troriluzole monotherapy at 100mg twice daily did not differentiate from placebo on the primary endpoint of the mean change from baseline on the Hamilton Anxiety Rating Scale (HAM-A) after eight weeks of treatment. After eight weeks of treatment, troriluzole treated subjects had a mean improvement change from baseline of -9.28 points [95% CI: -10.23 to -8.32] on the HAM-A total score versus -9.35 points [95% CI: -10.34 to -8.36] on placebo, p-value = 0.917. Troriluzole was well tolerated with a low discontinuation rate due to adverse events (troriluzole 4% versus placebo 4.5%). Comment: Earlier this year, troriluzole dosed at 280mg successfully advanced past an interim futility analysis in its pivotal Phase II/III trial in Alzheimer's disease study performed after 100 subjects completed 6 months of treatment. Completion of the troriluzole in Alzheimer's Disease trial is expected in 4Q2020, and topline data is anticipated from the troriluzole adjunctive therapy obsessive compulsive disorder (OCD) trial in 2Q2020 and from the troriluzole in SCA trial in 2021.
Condition: Generalised Anxiety Disorder