First Patient Enrolled In Biohaven’s Phase 2/3 Mild-To-Moderate Alzheimer’s Trial

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven” or the “Company”) announced today that it has enrolled the first patient in a Phase 2/3 clinical trial of trigriluzole (BHV-4157), a novel glutamate modulator for the treatment of mild-to-moderate Alzheimer’s disease (AD). The trial is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of trigriluzole in patients diagnosed with AD of mild-to-moderate severity (Mini-Mental State Examination scores of 14-24 at screening), and is being conducted in collaboration with the Alzheimer’s Disease Cooperative Study (ADCS) at sites throughout the U.S.

Howard Feldman, MD, FRCP, Director of the ADCS and Professor of Neurosciences at University of California San Diego School of Medicine added, “We are excited that the first patient has been enrolled into this innovative clinical trial that we are conducting with Biohaven. The preclinical evidence for the active metabolite of trigriluzole to modulate glutamate and confer neuroprotective effects in patients with AD is compelling, and the new formulation of trigriluzole should improve its pharmaceutical properties with potential for efficacy in AD.”

Alzheimer’s disease is a progressive, fatal neurodegenerative dementia that accounts for 60 – 80 percent of dementia cases. Alzheimer’s disease currently has no cure. Although there are FDA-approved medications for symptomatic treatment of AD, their clinical benefits are generally limited. Novel therapeutic approaches aimed at normalizing synaptic and extra-synaptic glutamate levels, such as trigriluzole, may offer the potential for symptomatic benefit in AD by improving cognitive function, as well as the potential for disease modification by preventing the loss of synapses.

Irfan Qureshi, M.D., Executive Director of Neurology at Biohaven, commented, “Biohaven is committed to efficiently developing novel therapies for severe neurological diseases so this is an important clinical milestone for the company. Based on compelling preclinical research, trigriluzole represents a promising therapeutic option for patients and families suffering from mild-to-moderate Alzheimer’s disease and we look forward to collaborating with the ADCS.”

Vlad Coric, M.D., CEO of Biohaven, added, “We are excited to advance trigriluzole in another late-stage clinical trial that reflects the broad therapeutic potential of trigriluzole in neurologic conditions. The trial, if positive, may contribute to the regulatory package necessary to establish the effectiveness of trigriluzole for the treatment of Alzheimer’s disease.”

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