Biohaven Pharma (BHVN) Reports First Patient Enrollment in Phase 2/3 Trial of Oral Zavegepant

March 29, 2021 7:32 AM EDT

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Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a marketed drug for the acute treatment of migraine and a portfolio of innovative, late-stage product candidates targeting neurological diseases including rare disorders, today announced that it has enrolled the first patient in a Phase 2/3 clinical trial of oral zavegepant for the preventive treatment of migraine.

In August 2020, Biohaven entered into a funding agreement with Royalty Pharma to secure up to $250 million to advance the development of zavegepant in migraine and other CGRP-mediated diseases. Biohaven previously received $150 million in funding and will now receive $100 million with the enrollment of this first patient in the oral zavegepant Phase 3 clinical trial.

Elyse Stock, M.D., Chief Medical Officer of Biohaven commented, "We are excited to advance the oral formulation of zavegepant into this late-stage, clinical trial and broaden our CGRP franchise. We plan on following the science of CGRP receptor antagonism into pain related disorders and non-migraine indications. By expanding beyond our migraine franchise, we are hoping to meet the needs of people impacted by the debilitating aspects of multiple CGRP-mediated diseases."

The randomized, double-blind, placebo-controlled trial will enroll approximately 2,900 people with migraine and will evaluate the efficacy and safety of 100 mg and 200 mg doses of oral zavegepant. For more information about the trial, visit clinicaltrials.gov.

"We are pleased to see Biohaven progress oral zavegepent into Phase 3 for the prevention of migraine, as people suffering from frequent migraines continue to need additional treatment options," said Jim Reddoch, PhD, Royalty Pharma's Co-Head of Research & Investments and Chief Scientific Officer. "Our successful, multi-year partnership with Biohaven to support both the regulatory approval and commercialization of Nurtec as well as pipeline development is an excellent example of how Royalty Pharma can be a collaborative partner to innovative biopharma companies."

The zavegepant program encompasses intranasal and oral formulations for migraine and non-migraine indications. Intranasal zavegepant previously demonstrated superior efficacy to placebo in a Phase 2/3 study for the acute treatment of migraine and the investigational agent is also being studied in an ongoing double blind, randomized, placebo-controlled trial in COVID-19 infected hospitalized patients requiring supplemental oxygen.



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