Biohaven Pharmaceutical said that it has initiated a Phase 2/3 study of its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist for the treatment of migraine. The company announced positive results from a Phase 1 study of BHV-3500 in February 2019.
The trial will compare 5, 10, and 20 mg doses of BHV-3500 delivered by Aptar Pharma’s Unit Dose System (UDS) to placebo and expects to enroll 400 subjects in each treatment arm. Topline results are expected by the end of the year.
Biohaven CEO Vlad Coric said, “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.”
Biohaven Chief Development Officer Robert Croop commented, “We are excited to advance BHV-3500, our third-generation CGRP receptor antagonist, into this Phase 2 trial to assess the best dose to move forward into a pivotal trial. The PK profile and intranasal administration differentiates BHV-3500 from other CGRP antagonists and may provide patients with an important new treatment option.”
Read the Biohaven Pharmaceutical press release.
