Biohaven Pharmaceutical has enrolled the first patient in its Phase III trial evaluating the efficacy and safety of rimegepant for migraine prevention.
The trial is expected to enrol adults who have suffered from migraines for at least one year.
It also intends to include individuals experiencing four to 14 moderate-to-severe migraines per month.
The trial’s primary objective is the change from baseline at week 12 in the mean number of migraine days per month.
Its secondary objectives comprise the achievement of at least a 50% reduction from baseline in mean monthly migraine days, as well as the mean number of rescue medication days per month, each measured during the trial’s double-blind, treatment phase.
Topline data is expected to be published next year.
Biohaven Pharmaceutical CEO Vlad Coric said: “If successful, our plans will be to develop rimegepant for both the acute and preventive treatment of migraines.
“Oral small molecule CGRP receptor antagonists with high receptor affinity and long half-lives, such as rimegepant, may possess dual-therapy action with the ability to provide both acute relief and preventive effects.
“Ongoing preliminary data from our long-term safety study suggests that rimegepant may have a role for both acute and preventive migraine treatment and has provided us with sufficient information to allow us to initiate this trial. Our intention is to develop convenient and easy to use CGRP-targeting formulations spanning from acute treatment to prevention.”
Last month, Biohaven announced it had started dosing patients in a clinical trial of its investigational small molecule CGRP receptor antagonist BHV-3500.
BHV-3500 is designed to be administered in an intranasal (IN) formulation.