Biohaven announces results from Phase 1 EEG study of BHV-7000

Biohaven announced preliminary analyses and positive biomarker data from Biohaven’s exploratory Phase 1 electroencephalogram, EEG, biomarker study, which was presented to epilepsy key opinion leaders at an off-site meeting held during the International Epilepsy Conference 2023 in Dublin, Ireland. The preliminary study results confirm central nervous system, CNS, activity of BHV-7000 at projected therapeutic concentrations, dose-dependent and time-dependent changes in EEG spectral power and are consistent with EEG effects observed with other antiseizure medications, ASMs, approved for the treatment of epilepsy. Biohaven’s Phase 3 program in focal epilepsy is anticipated to begin before the end of 2023. The Phase 1 EEG study showed dose-dependent and time-dependent increases in brain spectral power in healthy subjects. At the lowest dose of 10 mg, subjects with BHV-7000 concentrations greater than or equal toEC50 showed mean increases in EEG spectral power in beta and gamma bands that were not observed in the group of subjects with drug concentrations less than EC50. These changes in beta and gamma band activity were consistent with those previously reported for other ASMs. At the highest dose of 50 mg, increases in EEG spectral power were observed across all spectral bands and distributed over all cortical brain regions. BHV-7000 was well tolerated in the exploratory EEG study and the safety profile was consistent with the previously reported safety data from the Phase 1 SAD/MAD trial completed to date in healthy volunteers. Based on the results from the EEG study and preliminary safety profile in SAD/MAD trials, Biohaven plans on exploring three oral doses of BHV-7000 in the Phase 3 focal epilepsy program. This dosing approach with a Kv7 activator will allow for assessment of distinct target concentrations over a wide range, above and below projected efficacious EC50 drug concentrations, not previously feasible with drugs in this class.