First Patient Enrolled in Study of Oral CGRP Receptor Antagonist for Migraine
The first patient is enrolled in a phase 3 trial for the oral calcitonin gene-related peptide (CGRP) receptor antagonist rimegepant (Biohaven; New Haven, CT). The trial will assess the efficacy and safety of the drug for both acute and preventive treatment of migraine.
Rimegepant is the only oral CGRP receptor antagonist in development for both types of treatment. At this point, the drug has demonstrated efficacy and safety in 3 phase 2/3 trials. The new phase 3 trial will evaluate rimegepant for migraine prevention in adults who have suffered from migraine for at least 1 year with 4 to 14 migraine attacks of moderate to severe intensity per month during the 3 months before enrolling in the study.
The primary outcome for the trial at week 12 is the change from baseline in the mean number of migraine days per month. Secondary outcomes include at least a 50% reduction from baseline in monthly migraine days and the number of rescue medication days per month. Topline data from this trial is expected in 2019.
Vlad Coric, MD, CEO of Biohaven, said, "We are excited to enroll the first patient in our phase 3 trial evaluating rimegepant as a preventive therapy for migraine. If successful, our plans will be to develop rimegepant for both the acute and preventive treatment of migraine. Oral small molecule CGRP receptor antagonists with high receptor affinity and long half-lives, such as rimegepant, may possess dual-therapy action with ability to provide both acute relief and preventive effects. Ongoing preliminary data from our long-term safety study has provided us with sufficient information to allow us to initiate this trial.”