A Phase 1 Study to Evaluate Bioequivalence Between BHV ...

A Phase 1 Study to Evaluate Bioequivalence Between BHV-0223 40 mg Zydis? Sublingual Formulation and Riluzole 50 mg Oral Tablet in Healthy Volunteers

Irfan A. Qureshi1, Vladimir Coric1, Kimberly Gentile1, Richard Larouche2, Mario Tanguay2, Matt Anderson,3 Robert M. Berman1

1Biohaven Pharmaceuticals, Inc., New Haven, CT, USA 2Syneos Health, Qu?bec City, Canada 3Certara, Princeton, NJ

Dr. Berman is an employee and shareholder of Biohaven Pharmaceuticals

This material is being made available through Biohaven's Medical Affairs Department.

Background

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease

? The disease is characterized by progressive muscle weakness ? Median survival is 2 to 5 years following diagnosis

Riluzole prolongs survival and time to tracheostomy in patients with ALS

? The registration trial demonstrated a life extension of 2 to 3 months ? Postapproval observational studies suggest improved survival of 12 to 17 months ? Yet approximately half of diagnosed patients are not prescribed medication

The optimal use of riluzole in clinical practice is limited by...

? Difficulty swallowing (dysphagia) for many patients ? A food effect limiting bioavailability that requires fasting ? Dose-related hepatotoxicity

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Novel Sublingual Formulation

? Manufactured via a proprietary lyophilization process: Zydis? technology developed by Catalent Pharma Solutions

? Multiple prototypes and 3 years of formulation development

? Tablet rapidly dissolves in seconds when placed under tongue

BHV-0223: Novel Riluzole 40 mg Rapidly Dissolving Zydis Formulation

Designed to provide following attributes

No clinically meaningful food effect

PK,

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pharmacokinetics.

Study Objective: Bioequivalence Study in Healthy Volunteers

? Objectives

? Primary

? To compare the rate and extent of absorption of BHV-0223 40 mg with riluzole 50 mg tablet in healthy volunteers under fasting conditions

? To evaluate the effect of food on the PK of BHV-0223 40 mg

? Secondary

? To assess the safety and tolerability of BHV-0223 ? Assess the rate of absorption of BHV-0223 compared with crushed riluzole 50 mg tablet

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