Biohaven completes enrollment in Phase IIb/III of trigriluzole for spinocerebellar ataxia

Biohaven Pharmaceutical Holding Co. Ltd. (NYSE:BHVN) completed enrollment of about 180 patients with hereditary spinocerebellar ataxia in a Phase IIb/III trial evaluating once-daily 140 mg oral trigriluzole (BHV-4157) for 8 weeks. The company plans to submit an NDA to FDA for the product in early 2018.

The double-blind, placebo-controlled, U.S. trial’s primary endpoint is the change in total score on the Scale for the Assessment and Rating of Ataxia (SARA). Secondary endpoints include total time of the 8-meter walk, Sheehan Disability Scale, Patient and Clinician Global Impression of Change scales, safety and pharmacokinetics...