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Biohaven Completes Enrollment for Focal Epilepsy Trial

Biohaven has finalized enrollment for its RISE3 pivotal Phase 2/3 study, testing the drug opakalim as a treatment for refractory focal epilepsy. The company expects to release top-line results from the randomized, double-blind trial in the second half of 2026, marking a key step in its clinical development program.

Biohaven Completes Enrollment for Focal Epilepsy Trial
Photo: Bio & News

The study evaluates opakalim, a selective Kv7.2/7.3 channel activator, as an adjunctive therapy for adults experiencing at least four seizures per month while on existing medication. Unlike older antiseizure medicines, opakalim is designed to target neuronal excitability without interacting with GABA receptors, a mechanism intended to reduce common side effects such as dizziness, fatigue, and memory impairment.

Early clinical data supports this approach, with an open-label extension study showing that 54% of participants on a 75 mg daily dose achieved a seizure frequency reduction of at least 50%. Patient retention remains high, with roughly 95% of participants completing the double-blind treatment period across the RISE2 and RISE3 trials and opting to roll over into long-term extension studies. Dr. Jason Lerner, who leads the epilepsy development program at Biohaven, noted that the high completion rates reflect a positive patient experience with the drug’s tolerability profile. The company is currently conducting two parallel pivotal studies to determine the efficacy of the treatment against a placebo, aiming to offer an alternative that avoids the burdensome side effects associated with current standard therapies.

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