After rare disease failure, Biohaven pushes the gas on oral migraine drug

The company is expecting phase 3 readouts in the first quarter of 2018.

Biohaven Pharma has completed patient recruitment in a late-stage trial of migraine candidate rimegepant, which is looking like its best pipeline prospect after its rare-disease candidate hit a snag last month.

The company’s two phase 3 trials of the oral calcitonin gene-related peptide (CGRP) receptor antagonist—which Biohaven says is one of only two such drugs in late-stage development—are on course for a data readout in the first quarter of 2018. According to an earlier note from analysts Morgan Stanley, the drug is the biotech’s main 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 drug with the FDA that is a requirement for submitting it for approval in the U.S.

Free Daily Newsletter

Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

A few weeks ago, Biohaven cratered after its trigriluzole drug failed to show a benefit versus placebo in patients with the rare brain degenerative disease spinocerebellar ataxia. The company blamed a higher-than-expected placebo response. That development placed even more 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 verge of being commercialized for acute migraine, with Amgen and Novartis due to hear from the FDA on their Aimovig (erenumab) candidate by May 17 next year. If it is greenlighted by the regulator, it could have a brief window of opportunity with a trio of 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 plans to do so early next year.

All of these drugs are aimed at chronic migraine sufferers who experience attacks despite current drugs such as triptans, but Biohaven and Allergan hope their oral candidates could be used to nip a developing acute attack in the bud.

Biohaven’s CEO Vlad Coric, M.D., said 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 added.

Allergan will no doubt take issue with that assessment as it pushes its own oral CGRP duo—ubrogepant for acute migraine and atogepant for chronic migraine—into phase 3 and phase 2b studies respectively. The company licensed the two drugs from Merck & Co two years ago for $250 million upfront. Merck which shelved its earlier oral CGRP candidate telcagepant in 2011.