Biohaven has 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.

"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," Vlad Coric, M.D., CEO of Biohaven said. "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.

"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," Robert Croop M.D., Chief Development Officer – Neurology at Biohaven, said. "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.

Approximately 40 million Americans suffer from migraine. Acute attacks of migraine can differ in intensity and frequency, with many being highly disabling. More than 90 percent of migraine sufferers are unable to work or function normally during an attack. In the Global Burden of Disease Study, updated in 2015, migraine was ranked as the seventh highest cause worldwide of years lost due to disability. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine and are the first new class specific to the acute treatment of migraine in over 25 years. This unique and specific mode of action potentially offers an alternative to current agents, particularly for patients who have contraindications to the use of triptans, such as those with underlying cardiovascular diseases, or who either do not respond or have inadequate or inconsistent response to triptans or are intolerant to them.

Rimegepant is Biohaven's orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist, which the Company is developing as a treatment for migraine and refractory trigeminal neuralgia. The efficacy and safety profile of rimegepant for the acute treatment of migraine, as compared to placebo, has now been established across four randomized controlled trials to date: three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in all three Phase 3 trials are consistent with regulatory guidance from the FDA and provided the basis for Biohaven's NDA submission to the FDA in the second quarter of 2019.

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