Shares in Biohaven declined as much as 20% on Monday after the company announced top-line results from a Phase III trial indicating that troriluzole monotherapy was not significantly better than placebo at easing anxiety symptoms in patients with generalised anxiety disorder (GAD). CEO Vlad Coric said "these efficacy results were disappointing and do not support continued development of troriluzole as a monotherapy in GAD," but he noted that the company has "multiple ongoing studies evaluating troriluzole in other disease indications and with different dosing paradigms."
The latest study randomised 402 adults with GAD to receive Biohaven's third-generation glutamate modulator, also known as BHV 4157, twice daily or placebo, assessing the change in Hamilton Anxiety Rating Scale (HAM-A) scores from baseline to eight weeks as the primary endpoint.
Biohaven reported that after eight weeks of treatment, patients given troriluzole had a mean improvement change of -9.28 points on the HAM-A scale, versus -9.35 points for placebo. The company noted that troriluzole was well tolerated with a 4% discontinuation rate due to adverse events, compared to 4.5% in the placebo group.
Coric said "our strategy has been to test troriluzole in four distinct disorders where glutamate has been implicated in the underlying pathophysiology of the illnesses." Completion of the Phase II/III T2 Protect AD study testing troriluzole in mild-to-moderate Alzheimer's disease is expected in the fourth quarter of 2020. In addition, top-line data are anticipated in the second quarter of this year from a trial assessing troriluzole as an adjunctive therapy in obsessive compulsive disorder, and from another late-stage trial evaluating the drug in spinocerebellar ataxia in 2021.
Meanwhile, Biohaven said that in the first quarter of 2020, it is expecting an FDA decision regarding its application for the CGRP receptor antagonist rimegepant as a treatment for acute migraine, as well as top-line data from a rimegepant prevention trial. For related analysis, see ViewPoints: Biohaven solidifies its flexible anti-CGRP approach to migraine.
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