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Biohaven to Begin Phase 1 Testing of New CGRP BHV-3500

The new drug has a number of potential routes of administration.

See other CGRP drugs approved and in the pipeline here.

A PPM Brief

Biohaven announced the first participant to be dosed with BHV-3500, a third generation calcitonin gene-related peptide (CGRP) receptor antagonist. The company has filed an investigational new drug application (IND) for BHV-3500 in the treatment of migraine and has requested FDA authorization to proceed with clinical investigation. Biohaven's first clinical trial of BHV-3500 will explore a range of doses using intranasal administration.

Intranasal BHV-3500 is administered using the Aptar Pharma Unit Dose System (UDS) designed to enable systemic delivery of drugs, without the need for injection or administration by a healthcare professional. This device is approved within multiple drug products marketed in the US currently.

CGRPBHV-3500 is Biohaven's second CGRP-receptor antagonist to enter clinical trials. (Source: 123RF)

BHV-3500 is the second of Biohaven's CGRP-targeting compounds to enter clinical trials behind the company's multiple CGRP product candidates, such as rimegepant, for the acute treatment to prevention of migraine. “BHV-3500's intranasal dosing is complementary to our lead migraine asset rimegepant, which has established efficacy and safety in Phase 3 clinical trials,” said Vlad Coric, MD, CEO of Biohaven, in the company’s press release. “Intranasal BHV-3500 offers the potential for a rapid onset of action without the need for an injection.”

The physicochemical properties of BHV-3500 make the product potentially suitable for multiple routes of delivery including nasal, subcutaneous, inhalation or oral administration. Nonclinical proof-of-concept of BHV-3500 has been observed in a preclinical marmoset assay, and no cardiovascular safety or systemic toxicity issues have been observed in preclinical testing thus far.

Last updated on: December 10, 2018
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