Biohaven Pharmaceutical started a Phase 2/3 clinical trial of trigriluzole (BHV-4157), a novel glutamate modulator, in patients with mild-to-moderate Alzheimer’s disease (AD).
Biohaven kicked off this trial after getting FDA acceptance for investigational new drug application (IND) for trigriluzole in AD.
Vlad Coric, M.D., CEO of Biohaven, said that the Phase 2/3 trial has been designed to serve as a well-controlled trial that, if positive, may contribute to establishing the effectiveness of trigriluzole for the treatment of Alzheimer’s disease.
The trial will test trigriluzole in about 292 patients diagnosed with AD of mild-to-moderate severity patients, who will be randomized on a 1:1 basis to receive 280 mg of trigriluzole or placebo, taken orally at bedtime, for 11 months (48 weeks).