Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a biotechnology company focused on advancing innovative therapies for neurological and neuropsychiatric diseases, today announced that it enrolled the first patient in a Phase 2/3, double-blind, randomized, placebo-controlled, dose-ranging trial of intranasally administered BHV-3500 for the acute treatment of migraine. BHV-3500 is a novel, structurally distinct, third-generation calcitonin gene-related peptide (CGRP) receptor antagonist being developed by Biohaven.
In the trial, three doses of BHV-3500 (5, 10 and 20 mg) are being compared to placebo in the treatment of a migraine attack. With a planned enrollment of approximately 400 randomized subjects per treatment arm, the trial is powered to provide proof of efficacy on the regulatory endpoints of pain freedom and freedom from the most bothersome migraine-associated symptom at 2 hours post-dose. The trial is also designed to detect early onset of other clinical measures that are of great importance to patients, including pain relief and ability to return to normal functioning.
Vlad Coric, M.D., CEO of Biohaven, commented, “This is the first late-stage clinical trial designed to assess the efficacy of an intranasally administered CGRP receptor antagonist in the acute treatment of migraine. The PK profile from our recently completed Phase 1 trial suggests the potential for an ultra-rapid onset of action without the need for an injection. BHV-3500 is complementary to our lead migraine asset, rimegepant, which has met the primary efficacy endpoints in three completed Phase 3 clinical trials, with a favorable safety profile. We believe that intranasal BHV-3500 may provide people with ultra-rapid onset of migraine relief in a form that can easily be self-administered whenever and wherever a migraine strikes.”