Biohaven Ltd. has completed enrollment in a pivotal Phase 2/3 randomized, double-blind, placebo-controlled study evaluating its selective Kv7.2/7.3 channel activator opakalim for refractory focal epilepsy. The study, which enrolled adults with focal onset seizures who had at least four seizures per month while taking one to three concurrent antiseizure medicines (ASMs), is designed to measure the change from baseline in 28‑day average seizure frequency over an eight‑week treatment period. Participants were randomized to once‑daily opakalim at 75 mg or 50 mg, or placebo, as adjunctive therapy on a stable ASM regimen, following an eight‑week observation phase. Top‑line results are expected in the second half of 2026.
At its May 2026 R&D Day, Biohaven highlighted emerging data from ongoing studies in focal and idiopathic generalized epilepsy, describing evidence of target engagement, potential efficacy and a differentiated tolerability profile. In an open‑label extension in focal epilepsy, 54% of participants receiving opakalim 75 mg once daily achieved at least a 50% reduction in seizure frequency over any consecutive six‑month period compared with pre‑randomization baseline, with reported nervous system adverse events such as dizziness and fatigue occurring at lower rates than those seen with approved and investigational ASMs. Across the pivotal studies, about 95% of participants completed the double‑blind treatment period and a similar proportion opted to roll over into the extension study, reflecting high completion and rollover rates.
Opakalim (BHV‑7000) is described as a next‑generation, selective Kv7.2/7.3 potassium channel activator targeting a clinically validated mechanism for epilepsy, with substantially less activity at GABA receptors than earlier Kv7 activators. It has been studied in more than 1,000 participants across multiple trials, and Biohaven is conducting two pivotal Phase 2/3 studies and an open‑label extension to assess its efficacy and long‑term safety in refractory focal epilepsy.
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