Clinical TrialMay 27, 2026, 05:16 PM
Biohaven Reports Positive Clinical Data for Opakalim & Autoimmune Drugs
AI Summary
Biohaven Ltd. announced positive new clinical data for its selective Kv7.2/7.3 activator, opakalim, in epilepsy, demonstrating a 3-fold prolongation in time to second generalized tonic-clonic seizure in IGE and a 54% seizure frequency reduction in focal epilepsy with a favorable tolerability profile. Additionally, the company reported compelling positive clinical biomarker and patient data for its extracellular protein degraders, BHV-1300 for Graves' disease and BHV-1400 for IgA nephropathy, showing deep and rapid lowering of disease-driving antibodies. Pivotal Phase 3 trials for both autoimmune programs are set to begin by mid-2026.
Key Highlights
- Opakalim prolonged median time to second generalized tonic-clonic seizure by 3-fold (141 days vs. 47 days placebo) in idiopathic generalized epilepsy.
- 54% of focal epilepsy patients on opakalim achieved a ">=50% reduction" in seizure frequency over any consecutive six months.
- Opakalim demonstrated a differentiated tolerability profile with low rates of CNS adverse events, including 0% somnolence/dizziness in IGE and 5% dizziness in focal epilepsy.
- BHV-1300 achieved ">80% mean reduction" in pathogenic TSHR autoantibodies in Graves' disease patients over 12 weeks.
- BHV-1400 showed a ">60% mean reduction" of Gd-IgA1 within hours and 70% within one month in IgA nephropathy patients.
- BHV-1300 normalized thyroid hormones (T4 in 3 weeks, T3 in 5 weeks) in Graves' hyperthyroidism patients.
- Pivotal Phase 3 trials for BHV-1300 and BHV-1400 are scheduled to initiate by mid-2026.
- Opakalim is on track for top-line results from pivotal Phase 2/3 refractory focal epilepsy studies in 2H 2026.
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