Biohaven has concluded enrolment in the pivotal RISE3 Phase II/III trial assessing the selective Kv7.2/7.3 channel activator, opakalim (BHV-7000), for refractory focal epilepsy.
Topline data from the double-blind, randomised, placebo-controlled trial is expected in the second half of 2026 (H2 2026).
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The trial enrolled adults with refractory focal onset seizures who experienced at least four seizures per month and were taking one-to-three concurrent anti-seizure medicines.
After an eight-week observation phase, participants were randomised in a 1:1:1 ratio to receive either 75mg or 50mg of opakalim, or placebo as adjunctive therapy for an eight-week double-blind treatment period.
The main endpoint tracks change in 28-day average seizure frequency against baseline. RISE2 is ongoing, with the same enrolment criteria and outcome measures, and is evaluating 25mg, 50mg and 75mg dosages of opakalim.
Opakalim is designed as a once-daily oral therapy to control seizures without the need for titration and without central nervous system side effects often reported with approved and investigational anti-seizure medicines.
Data from the ongoing focal epilepsy open-label extension (OLE) study indicated that 54% of participants on 75mg of opakalim daily achieved a 50% or greater reduction in seizure frequency over any consecutive six months compared to baseline.
The results also showed a tolerable side effect profile and notably lower rates of nervous system adverse events than current anti-seizure medicines.
Approximately 95% of participants who completed the double-blind period in RISE2 and RISE3 entered the optional OLE study.
Biohaven research and development medical director and epilepsy development lead Jason Lerner said: “Completing enrolment in RISE3 marks an important milestone for the opakalim development programme and brings us one step closer to offering people living with focal epilepsy a new treatment option that meaningfully controls seizures without compromising their quality of life.
“The high completion and rollover rates we continue to see reflect the favourable experience that patients and investigators have with opakalim’s profile. We look forward to reporting topline results in the second half of 2026, and we extend our deep gratitude to the patients who are participating in this study and to the sites whose dedication makes this possible.”
In December 2025, Biohaven announced findings from its Phase II proof-of-concept trial of BHV-7000 in adults with major depressive disorder, focusing on the reduction of depressive symptoms as measured by the Montgomery Åsberg Depression Rating Scale over six weeks.
