EEG Biomarker and Safety Data Reported for BHV-7000, A Potassium Ion Channel Activator Under Investigation for Epilepsy Treatment
Biohaven Pharmaceuticals (New Haven, CT) announced results from its phase 1 study of BHV-7000, a novel small molecule Kv7.2/7.3 potassium ion channel activator under consideration as a potential treatment for epilepsy. The results, which were presented at the 2023 American Epilepsy Society (AES) Annual Meeting, showed that at all doses tested, BHV-7000 was well tolerated by participants in the trial. Additionally, analysis of electroencephalogram (EEG) spectral power indicated dose-dependent pharmacodynamic effects at all frequency bands, with the greatest increases in spectral power at the alpha, beta, and gamma bands.
This was a phase 1 open label clinical trial that included 11 healthy adult participants aged 18 to 55 years. On days 1, 5, and 9, participants received single doses of BHV-7000 at 10 mg, 25 mg, and 50 mg in randomized sequence. Participants were assessed by EEG at baseline and throughout the study. Pharmacodynamic effects were assessed by quantitative spectral analysis and cluster-based permutation analysis.
Jason Lerner, MD, Medical Director and Epilepsy Clinical Lead at Biohaven Pharmaceuticals, commented on the announcement: "Selective Kv7 activators are one of the most exciting new drug targets for the treatment of epilepsy, and BHV-7000 has shown a favorable and differentiated profile in preliminary Phase 1 studies to date. We are pleased to see favorable safety and tolerability with BHV-7000 dosed up to 120 mg daily for 15 days, without the CNS adverse effects typically associated with other ASMs, such as somnolence. Together with the preclinical data showing BHV-7000 is a selective Kv7.2/7.3 channel opener lacking GABAA activation and the results from our Phase 1 EEG study confirming target engagement, we are excited to advance BHV-7000 into late-stage development in epilepsy patients."
The study authors are affiliated with Biohaven Pharmaceuticals, and the company also funded this clinical study.