Biohaven announces positive data from EEG biomarker study of epilepsy treatment
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A global clinical-stage biopharmaceutical company announced positive biomarker data from its exploratory phase 1 electroencephalogram biomarker study of novel and selective Kv7.2/Kv7.3 activator BHV-700 to treat epilepsy.
According to a release from Biohaven, the study was designed to evaluate qualitative changes from baseline in EEG spectral power following single 10 mg, 25 mg or 50 mg doses of BHV-7000 in healthy volunteers.
EEG spectral power is a measure derived from quantitative analysis of EEG signals that examine rhythmic activity at different frequencies, including delta [1-3.5 Hz], theta [3.5-7.5 Hz], alpha [7.5-13 Hz], beta [13-30 Hz] and gamma [30-100 Hz], per the release.
According to data cited in the release, at the lowest dose of 10 mg given to 12 participants, those with BHV-7000 concentrations at or greater than EC50 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.
Further, in 11 participants given the highest dose of 50 mg, increases in EEG spectral power were observed across all bands and distributed over all cortical brain regions.
The study additionally revealed BHV-7000 was well-tolerated, and its safety profile was consistent with prior safety data from the phase 1 SAD/MAD trial completed to date, which recorded a “markedly” lower incidence of somnolence, speech disorder and memory impairment.
“The EEG data confirms central nervous system target engagement as measured by dose-dependent changes in spectral power in expected frequency bands and over the entire head,” Biohaven Chairman and CEO Vlad Coric, MD, said in the release. “These EEG results along with the safety data from the phase 1 studies and our formulation group's development of a once-daily extended-release drug formulation of BHV-7000, allow us to advance to pivotal trials later this year.”
Biohaven expects a phase 3 program in focal epilepsy to commence before the end of the year.