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Biohaven Pharmaceutical has enrolled the first subject in a Phase II/III clinical trial of oral zavegepant for the preventive treatment of migraine.

A high affinity, selective and structurally unique, third generation, CGRP receptor antagonist, zavegepant is being developed for migraine, as well as non-migraine CGRP-mediated diseases.

The randomised, double-blind, placebo-controlled trial will have approximately 2,900 participants with migraine.

It will analyse the efficacy and safety of 100mg and 200mg doses of oral zavegepant.

In August last year, Biohaven signed a funding agreement with Royalty Pharma to secure up to $250m to advance the development of zavegepant in migraine and other CGRP-mediated diseases.

Biohaven has already received $150m in funding and will now get $100m with the enrolment of the first patient in the oral zavegepant Phase III trial.

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Royalty Pharma Research & Investments co-head and chief scientific officer Jim Reddoch said: “We are pleased to see Biohaven progress oral zavegepent into Phase III for the prevention of migraine, as people suffering from frequent migraines continue to need additional treatment options.

“Our successful, multi-year partnership with Biohaven to support both the regulatory approval and commercialisation 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 programme comprises intranasal and oral formulations for migraine and non-migraine indications.

In a Phase II/III study for the acute migraine treatment, intranasal zavegepant had showed superior efficacy as compared with placebo.

Furthermore, the investigational agent is being studied in an ongoing double-blind, randomised, placebo-controlled trial in hospitalised Covid-19 patients needing supplemental oxygen.

Biohaven chief medical officer Elyse Stock said: “We are excited to advance the oral formulation of zavegepant into this late-stage, clinical trial and broaden our CGRP franchise.

“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.”