Biohaven Reaches Targeted Therapeutic Exposures of BHV-3500

Biohaven announced that administration of intranasal BHV-3500 in a Phase 1 clinical trial has achieved targeted therapeutic exposures and that the compound will advance into a Phase 2 trial to evaluate efficacy for the acute treatment of migraine. BHV-3500 is a novel, third generation calcitonin gene-related peptide (CGRP) receptor antagonist being developed by Biohaven.

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

Intranasal BHV-3500 utilizes the Aptar Pharma Unit Dose System (UDS), which is designed to enable systemic delivery of drugs without the need for injection or administration by a healthcare professional. This device is FDA-approved with multiple drug products marketed in the United States using the Aptar technology and is used by thousands of people every day. Biohaven's Phase 1 clinical trial of the intranasal administration of BHV-3500 explored a broad dose range to characterize the PK profile and initial safety of the drug candidate in humans.

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

BHV-3500 is a novel CGRP receptor antagonist and Biohaven's second small molecule migraine drug candidate from its NOJECTION platform. BHV-3500 is structurally distinct from rimegepant and has novel properties including high water solubility and a high free fraction. The physicochemical properties of BHV-3500 make the drug candidate potentially suitable for multiple routes of delivery, including nasal, inhalation or oral administration. It is initially in development as an intranasal formulation for the acute treatment of migraine.

Rimegepant is Biohaven's orally-dosed CGRP receptor antagonist drug candidate being developed as an acute and preventative treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. The efficacy and safety profile of rimegepant for the acute treatment of migraine has now been observed across four randomized controlled trials to date: three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in the Phase 3 trials are consistent with regulatory guidance from the U.S. Food and Drug Administration (FDA). Biohaven plans to submit a new drug application (NDA) for rimegepant to the FDA in 2019.

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