Opakalim (BHV-7000) - (RISE-3)

June 30, 2026: Biohaven Ltd. (NYSE: BHVN) announced completion of enrollment in RISE3 (NCT06309966), a pivotal Phase 2/3 randomized, double-blind, placebo-controlled study of opakalim (BHV-7000), a selective Kv7.2/7.3 channel activator, as adjunctive therapy for refractory focal onset epilepsy. Top-line results are expected in 2H 2026. RISE3 includes an 8-week baseline observation period followed by 1:1:1 randomization to opakalim 75 mg, opakalim 50 mg, or placebo once daily for an 8-week double-blind treatment period; the primary endpoint is change from baseline in 28-day average seizure frequency.

The company also highlighted ongoing RISE2 (NCT06132893), which has similar criteria/endpoints with a 12-week double-blind period and evaluates 25 mg/50 mg (Part A) and 75 mg (Part B).

From the ongoing focal epilepsy open-label extension (NCT06443463), Biohaven reported that 54% of participants on opakalim 75 mg QD achieved a ≥50% seizure-frequency reduction over any consecutive six months vs pre-randomization baseline (n>100), with reported nervous system adverse events including 5% dizziness and 4% fatigue. Across RISE2/RISE3, ~95% completed double-blind treatment and ~95% rolled into the OLE.