Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases today reported completion of enrollment in its pivotal Phase 3 preventive treatment of migraine trial with rimegepant, its lead oral calcitonin gene-related peptide (CGRP) receptor antagonist product candidate.
Vlad Coric, M.D., CEO of Biohaven commented, “Given rimegepant’s high affinity for the CGRP receptor and its relatively long half-life, we believe rimegepant may possess unique “dual-therapy” action with a potential ability to provide acute treatment of migraine attacks and preventive effects. We are excited to complete enrollment in this Phase 3 preventive trial. To our knowledge, rimegepant is currently the only small molecule CGRP antagonist being developed for both the acute and preventive indications in the treatment of migraine.”
The Phase 3 trial of rimegepant in the preventive treatment of migraine examines the efficacy and safety of rimegepant in adult subjects who have suffered from migraine for at least one year and who have a frequency of 4 to 14 migraine attacks of moderate to severe intensity per month over the three months prior to enrollment. The primary outcome measure is the change from baseline at week 12 in the mean number of migraine days per month. Secondary outcome measures include the achievement of at least a 50% reduction from baseline in mean monthly migraine days across the double-blind treatment phase, and the mean number of rescue medication days per month, each as measured over the course of the double-blind, treatment phase.
Robert Croop M.D., Chief Development Officer – Neurology at Biohaven, commented, “Migraine is the 6th most disabling illness in the world, where more than 90% of sufferers are unable to work or function normally during an attack. Our hope is to bring forward a new oral therapy that is convenient for patients to administer, fulfills their needs for acute and preventive therapies, and has the potential to give back to these migraine sufferers significant portions of their lives otherwise lost to disability caused by migraine.”
Rimegepant has demonstrated efficacy and safety in four Phase 2/3 trials in the acute treatment of migraine and Biohaven submitted New Drug Applications (NDAs) to the FDA for the Zydis ODT and tablet formulations of rimegepant in 2Q2019. Biohaven is also developing its product candidate BHV-3500, the first small molecule CGRP receptor antagonist to be administered in an intranasal (IN) formulation in human testing. Biohaven’s pipeline now includes product candidates across three novel mechanisms of action to target central nervous system disorders: 1) CGRP receptor antagonists for migraine and pain; 2) glutamate modulating agents for the treatment of neurological and neuropsychiatric disorders, and; 3) myeloperoxidase inhibition for neuroinflammatory disorders. The Company expects to reach significant pipeline milestones in the coming periods. – PR Newswire