Biohaven Pharmaceutical Holding has begun patient enrolment in the first of two Phase III clinical trials planned for its product candidate rimegepant (BHV-3000) for acute treatment of migraine.
Rimegepant is an oral selective and potent small molecule antagonist of CGRP receptor.
The two double-blinded, placebo-controlled Phase III trials are designed to assess the efficacy and safety of 75mg of rimegepant with co-primary endpoints of freedom from pain and a demonstrated effect on the most challenging symptom two hours after dosing.
Biohaven CEO Vlad Coric said: "Based on the results of its Phase IIb clinical trial, we believe rimegepant has the potential to be a best-in-class treatment option, combining early, comprehensive, and durable efficacy with convenient oral dosing, so that patients are spared the need for any intravenous or subcutaneous administration."
In the Phase IIb trial, 75mg of rimegepant demonstrated statistically significant improvement in pain, nausea, photophobia and phonophobia at two hours after dosing when compared to placebo.
The product candidate further showed durable efficacy with a statistically higher pain freedom rate at 24-48 hours following dosing.
Biohaven plans to begin enrolment in its second Phase III trial in the coming months, with plans to report top-line results from both trials in the first half of next year.
The firm intends to perform a long-term safety study of rimegepant to demonstrate low cardiovascular side effects risk, favourable safety profile and sustained effects.
Patients recruited for the Phase III trials will also be eligible for the long-term safety study.