Healthcare
Biohaven Completes Enrollment in RISE 3 Pivotal Focal Epilepsy Study with Opakalim, a Selective Kv7.2/7.3 Activator
Biohaven Ltd. (NYSE: BHVN), a global clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced the completion of enrollment in RISE3, a pivotal Phase 2/3 randomized, double-blind, placebo-controlled studies evaluating its selective Kv7.2/7.3 channel activator, opakalim, for the treatment of refractory focal epilepsy. Top-line results from the study are expect
About this update from Biohaven Ltd.
NEW HAVEN, Conn., June 30, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a global clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced the completion of enrollment in RISE3, a pivotal Phase 2/3 randomized, double-blind, placebo-controlled studies evaluating its selective Kv7.2/7.3 channel activator, opakalim, for the treatment of refractory focal epilepsy. Top-line results from the study are expected in 2H 2026. For the many people whose focal seizures remain uncontrolled despite available treatment, new options are urgently needed — and too often, the medicines meant to control seizures carry their own daily burden, from dizziness and drowsiness to fatigue and memory problems that can affect work, relationships, and independence. Opakalim is being developed to help control seizures without adding to that burden. Opakalim offers potential for easy-to-use, once-daily, orally administered treatment without the need for titration to control seizures, and without the burdensome central nervous system side effects frequently reported with approved and investigational antiseizure medicines (ASMs). Opakalim demonstrates selectivity for Kv7.2/7.3 heteromeric channels and lacks GABA receptor activity, distinguishing it from other investigational Kv7 activators. RISE3 (NCT06309966) enrolled adult participants with refractory focal onset seizures who experienced at least four seizures per month and took one to three concurrent ASMs, consistent with criteria used in other recent focal epilepsy ASM trials. Following an 8-week observation phase to establish baseline seizure frequency, participants were randomized (1:1:1) to one of two doses of opakalim (75 mg and 50 mg) or placebo once daily, as adjunctive therapy on a stable background regimen of ASMs, for an 8-week double-blind treatment period. The primary endpoint measures the change from baseline in 28-day average seizure frequency during the treatment phase. RISE2 (NCT06132893) is ongoing and has identical entry criteria and endpoints with a 12-week double-blind treatment period and evaluates opakalim 25 mg and 50 mg once-daily in Part A and 75 mg once-daily in Part B.