Biohaven Announces Submission of IND for BHV-3500

Biohaven has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate the safety and tolerability of BHV-3500, the first small molecule calcitonin gene-related peptide (CGRP) receptor antagonist to be advanced into the clinic in an intranasal formulation. BHV-3500 is the second of Biohaven's CGRP-targeting compounds to reach this developmental milestone. Biohaven's multiple CGRP product candidates, including rimegepant, and formulations including oral tablet, Zydis (Catalent) rapid dissolving tablet and intranasal delivery are designed to meet patients needs for both acute treatment and prevention of migraine.

"BHV-3500 has novel properties including high water solubility and a high free fraction which allows for a low dose that we believe is well suited to intranasal delivery," said Charlie Conway, Ph.D., Chief Scientific Officer of Biohaven. "BHV-3500 also exhibits high affinity binding to the human CGRP receptor with a preference to remain bound to the receptor much longer than unbound, and when paired with intranasal administration has the potential for both rapid onset of action and sustained activity."

Biohaven's 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 approved with multiple drug products marketed in the United States using the Aptar technology and is used by thousands of people every day in a range of scenarios.

"People with migraine seek rapid, long-lasting, convenient, and non-invasive treatments. We are pleased to advance BHV-3500 toward first in human dosing and look forward to expanding our current CGRP platform. BHV-3500's intranasal dosing has the potential to complement rimegepant, which has established efficacy and safety in Phase 3 clinical trials, and provides convenient dual options of a traditional tablet and a rapid dissolving oral formulation," said Elyse Stock, M.D., Chief of Portfolio Strategy and Development. "We believe it is important for migraine sufferers to have a range of dosing options for the acute and preventive treatment of migraine and look forward to expanding our CGRP platform with the addition of intranasal delivery and the potential for rapid onset."

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