Biohaven Pharma has finished its patient recruitment in a late-stage trial of a migraine drug candidate rimegepant, which is shaping up to be its best pipeline prospect following its rare-disease candidate hit a wall in October.
The company’s two phase 3 trials of the oral calcitonin gene-related peptide (CGRP) receptor antagonist—which Biohaven reported is one of only two drugs in late-stage development—are on pace for a data display in the Q1 of 2018. According to an statement from analysts Morgan Stanley, the treatment is the biotech’s top value driver with potential sales of $1.4 billion.
While it waits for the results of its pivotal program, Biohaven has also agreed on a protocol for a pediatric study of the candidate with the GDA that is a necessity for submitting it for approval in the United States.
A couple weeks back, Biohaven fell after its trigriluzole drug failed to display a benefit compared to its placebo in patients with the rare brain disease called spinocerebellar ataxia. The company put the fault on its higher-than-anticipated placebo response. That development put a stronger emphasis on rimegepant as it competes with Allergan to bring the first oral drug in the CGRP class to market.
Injectable CGRP drugs are on the cusp of being commercialized for acute migraine, with Amgen and Novartis set to hear from the FDA on their Aimovig (erenumab) candidate by May of 2018. If it is approved, it could have a small window of opportunity with three other injectables—Lilly’s galcanezumab, Teva’s fremanezumab and Alder’s eptinezumab—in late-stage development. Lilly and Teva have both filed their candidates for approval while Alder expects to do so early next year.
These drugs are focused to help chronic migraine sufferers who experience attacks despite current drugs such as triptans, though Biohaven and Allergan hope their oral candidates could be used to stop a developing acute attack in its tracks.
Biohaven’s CEO Vlad Coric, M.D., stated that the phase 3 trial enrolled its 1,400-patient target in just four months, which “reflects the high unmet need of people with migraine and dissatisfaction with current treatment approaches.”
“Based upon our phase 2 data, we believe our lead candidate, rimegepant, has the potential to be a best-in-class and first-in-class treatment option for the acute treatment of migraine,” he concluded.