Biohaven Starts Key Trial for New Migraine Drug

Biohaven Ltd. has commenced a critical Phase 2 clinical trial to evaluate BHV-2100, an innovative orally administered TRPM3 antagonist, for the acute treatment of migraines. This novel, non-opioid treatment has shown promise as a potential first-in-class therapy for addressing pain associated with migraines, adding a new option to the migraine treatment landscape.

Migraine remains a significant health issue, affecting 40 million people in the US and 1 billion worldwide. Despite advancements in treatment, many patients still suffer from inadequate relief, experiencing substantial disability and burden due to migraines. Biohaven's new trial aims to address this unmet need by testing the efficacy and safety of BHV-2100, a potent and selective TRPM3 antagonist.

Richard B. Lipton, M.D., a leading expert in neurology and director of the Montefiore Headache Center, highlighted the importance of this trial. He noted that there is a pressing need for new migraine treatments, as many existing therapies are plagued by tolerability issues and insufficient relief. The TRPM3 ion channel has been linked to the pathophysiology of migraines, making it a promising target for new treatments. This trial marks the first time the efficacy and tolerability of a TRPM3-targeting agent in migraine treatment are being assessed.

The Phase 2 study is a randomized, double-blind, placebo-controlled trial that will test two doses of BHV-2100 (75 mg and 150 mg) for the acute treatment of migraines. The trial will include around 575 patients across 60 sites in the United States. The primary endpoints for the trial, which have been accepted by the FDA, include pain freedom and freedom from the most bothersome symptom within 2 hours of administration.

Beth Emerson, M.D., M.B.A., Executive Medical Director at Biohaven, emphasized the company's commitment to developing novel therapeutic options for migraine sufferers. She expressed enthusiasm for the potential of BHV-2100 to offer a new, cutting-edge therapy, particularly for the estimated one-third of US migraine patients who do not respond to existing treatments.

BHV-2100 has shown excellent safety and tolerability in Phase 1 trials, with no significant thermoregulatory adverse events or sedative effects typically associated with other pain medications. The drug's pharmacokinetic profile is particularly suited for acute migraine treatment, demonstrating rapid absorption and sustained effective concentrations within 20 minutes of administration, reaching peak levels in 1.5 to 2 hours, and maintaining a half-life of 8-12 hours.

Beth Morris, Vice President of Biohaven Clinical Operations, praised the clinical operations team for swiftly advancing the trial to Phase 2 following the successful completion of Phase 1 earlier this year. She highlighted the urgency of developing new treatment options for migraine patients, underscoring the potential of BHV-2100 to meet this critical need.

Biohaven Ltd. is a biopharmaceutical company dedicated to discovering, developing, and commercializing transformative treatments for various diseases, including migraine, epilepsy, neuroinflammatory disorders, and cancer. The company's innovative therapeutic portfolio leverages its extensive drug development expertise and includes multiple proprietary platforms targeting key therapeutic areas.