Biohaven Pharmaceutical announced the successful completion of a Phase 1 trial of its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist and said that the company plans to initiate a Phase 2 efficacy trial in the second quarter of 2019.
Biohaven CEO Vlad Coric said, “We are excited to report that intranasal administration of BHV-3500 in our Phase 1 trial achieved drug exposures that we believe will be therapeutic in the acute treatment of migraine. Additionally, the PK profile of intranasal BHV-3500 demonstrated the earliest Tmax that we have observed with a small molecule CGRP receptor antagonist and 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 shown efficacy and safety in three Phase 3 clinical trials. We are now a step closer to our goal of providing migraine sufferers with a range of noninvasive, CGRP receptor antagonist dosing options for both the acute and preventive treatment of migraine.”
Biohaven Chief Development Officer, Neurology, Robert Croop said, “We are pleased to advance our next generation of CGRP receptor antagonist into further clinical development. If approved, this important component of our Nojection platform potentially offers patients a simple to use intranasal formulation in this new approach to treating migraine. We believe that intranasal BHV-3500 may provide people with migraine rapid onset of relief in a form that can easily be self-administered whenever and wherever a migraine strikes.”
Read the Biohaven Pharmaceutical press release.
