Biohaven Pharmaceutical has concluded patient enrolment in a Phase II/III clinical trial of vazegepant being developed for the treatment of migraine.
Based on the company’s Nojection Migraine platform, vazegepant is an antagonist of calcitonin gene-related peptide (CGRP) receptor. The drug has been formulated for intranasal administration.
The intranasal administration is made possible by Aptar Pharma’s Unidose System (UDS) intended for systemic drug delivery.
UDS holds US Food and Drug Administration (FDA) approval and does not require injection or a healthcare professional to administer.
The double-blind, randomised, placebo-controlled, dose-ranging Phase II/III trial is being conducted to assess the efficacy of the drug at 5mg, 10mg and 20mg doses, compared to placebo.
A total of more than 2,100 patients have been recruited for the study.
Vazegepant’s efficacy will be measured as freedom from pain and the most bothersome migraine-related symptom two hours after dosing.
The trial will also evaluate additional clinical measures, including pain relief and the return to normal functioning.
Biohaven Pharmaceutical CMO Elyse Stock said: “Our Phase II/III trial of vazegepant represents the first late-stage study of an intranasally delivered CGRP receptor antagonist, propelling us a step closer to providing patients with multiple, easy-to-use formulations to treat migraine.
“Vazegepant is complementary to our lead migraine asset, rimegepant, which has met the primary efficacy endpoints in three completed Phase III clinical trials and is currently under review with the FDA.”
Apart from vazegepant and rimegepant, the company’s portfolio of CGRP receptor antagonists includes multiple other candidates for the acute preventive treatment of migraine.
Last month, Biohaven completed enrolment of more than 1,600 patients in a Phase III trial of rimegepant.