NEW HAVEN, US - Biohaven Pharmaceutical Holding Company Ltd. (Biohaven) announced that the company has completed enrollment in its clinical study of trigriluzole (BHV-4157) in patients with spinocerebellar ataxia (SCA). Trigriluzole, a novel drug candidate being developed by Biohaven, has received both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) as a potential treatment for SCA. SCA is a rare, debilitating neurodegenerative disorder that is estimated to affect approximately 22,000 people in the United States. No medications are currently approved for this often severe condition.
“The completion of enrollment in this trial represents an important milestone for our glutamate modulating program in neurologic illnesses. We would like to thank the patients with SCA who are participating in this trial, the National Ataxia Foundation, and the clinical research sites for helping us to meet our enrollment target in such a timely fashion,” said Vlad Coric, M.D., Chief Executive Officer at Biohaven. “We are acutely aware of the high unmet medical need in SCA, and if the results of the trial are positive, we expect to submit a new drug application to the FDA in early 2018.”
About the Trigriluzole Trial in SCA
Biohaven’s SCA trial is a randomized, double-blind, placebo controlled, multi-center study designed to compare the safety and efficacy of once-daily oral therapy with trigriluzole 140 mg versus placebo. The study has now fully enrolled with approximately 180 adult SCA patients and is being conducted at 18 centers in the United States.
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