Announcement • Jul 01

Biohaven Completes Enrollment In RISE3 Pivotal Phase 2/3 Study Evaluating Opakalim In Focal Epilepsy

Biohaven completed enrollment in RISE3, a pivotal Phase 2/3 randomized, double-blind, placebo-controlled study 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 the second half of 2026. RISE3 (NCT06309966) enrolled adult participants with refractory focal onset seizures who experienced at least four seizures per month and took one to three concurrent antiseizure medicines, consistent with criteria used in other recent focal epilepsy antiseizure medicine 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 antiseizure medicines, 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. In the ongoing focal epilepsy open-label extension study, 54% of participants on opakalim 75 mg once-daily achieved a =50% reduction in seizure frequency compared to pre-randomization baseline, with a markedly lower incidence of nervous system adverse events compared to approved and investigational antiseizure medicines. High double-blind completion rates of approximately 95%, and high rollover rates into the open-label extension of approximately 95%, reflect favorable patient experience with opakalim. 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. Opakalim demonstrates selectivity for Kv7.2/7.3 heteromeric channels and lacks GABA receptor activity, distinguishing it from other investigational Kv7 activators. A recent analysis from the ongoing focal epilepsy open-label extension study demonstrated that 54% of participants on opakalim 75 mg once daily achieved a =50% reduction in seizure frequency over any consecutive six months of treatment compared to pre-randomization baseline (n>100), alongside a favorable tolerability profile and markedly lower incidence of nervous system adverse events (e.g., 5% dizziness, 4% fatigue) compared to approved and investigational antiseizure medicines. To date, approximately 95% of participants who reached the end of the double-blind treatment period in the pivotal Phase 2/3 studies (RISE2 and RISE3) completed it; and approximately 95% of those participants rolled over into the optional open-label extension study. Opakalim (BHV-7000) represents a next-generation, selective Kv7.2/7.3 potassium channel activator targeting a clinically validated mechanism of action for the treatment of epilepsy. Opakalim is differentiated from both first- and second-generation Kv7 activators by its selectivity for the Kv7.2/7.3 heteromeric channels that are the predominant regulators of neuronal excitability, with substantially less activity at GABA receptors. This selectivity profile is hypothesized to underlie opakalim's favorable tolerability, including the low rates of somnolence, dizziness, and fatigue observed in clinical studies to date. Opakalim has been studied in more than 1,000 participants across multiple clinical trials, consistently demonstrating a favorable tolerability profile. Biohaven is currently conducting two pivotal Phase 2/3 randomized, double-blind, placebo-controlled studies (NCT06132893 and NCT06309966) comparing the efficacy of opakalim to placebo as an adjunctive therapy for refractory focal onset epilepsy, as well as an open-label extension study (NCT06443463) to evaluate its long-term efficacy and safety.

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