Biohaven Doses First Subject in Bioequivalence Study with BHV-0223

Biohaven and its wholly owned subsidiary, Biohaven Pharmaceuticals announced the first subject was dosed in its bioequivalence study designed to demonstrate the pharmacokinetic equivalence of sublingual BHV-0223 compared to Rilutek (riluzole).

Biohaven is developing BHV-0223, a sublingual formulation of riluzole, as a potential treatment for patients with Amyotrophic Lateral Sclerosis (ALS). Previously, the Company reported that the FDA had concluded its review of the investigational new drug (IND) application and notified Biohaven that it may proceed with its clinical program. Biohaven previously received regulatory feedback from the FDA that the Section 505(b)(2) pathway is acceptable for BHV-0223 in ALS, and that no additional efficacy or toxicology studies are necessary for submission of a new drug application (NDA) for this indication.

BHV-0223 is an innovative sublingually administered and orally dissolving tablet (ODT) formulation of riluzole, a glutamate modulating agent, which is designed to advance beyond the current limitations of riluzole tablets. While riluzole tablets are FDA-approved for ALS, they may be difficult to administer in ALS patients, who often have dysphagia or trouble swallowing. The riluzole tablets also have certain pharmacokinetic (PK) and pharmaceutic limitations, including being associated with a negative food effect that can result in uncertain PK performance (low bioavailability) due to patients not fasting one hour before or two hours after taking the tablets. BHV-0223 is unique in that it utilizes the Zydis ODT fast-dissolve, dosing technology developed under an exclusive worldwide agreement with Catalent. In a Phase 1 clinical trial, 35 mg BHV-0223 was associated with less PK variability than 50 mg Rilutek tablets.