Biohaven provides updates on key programs

Biohaven earlier announced multiple updates on key programs including: preliminary EEG data from its lead investigational agent, BHV-7000, from the Kv7 activator program; Phase 1 update on its brain-penetrant dual TYK2/JAK1 inhibitor, BHV-8000; development update on its IgG degrader, BHV-1300, from the bispecific platform; and a regulatory update on troriluzole. Biohaven reported interim data from an electroencephalogram biomarker study with the initial, low-dose of BHV-7000 studied in healthy volunteers. Preliminary Phase 1 data confirmed evidence of target engagement in the central nervous system for subjects with projected therapeutic concentrations of BHV-7000, measured by changes from baseline in EEG spectral power that occurred after dosing, Biohaven said. The results from the low-dose group validate the preclinical hypothesis, confirm the Phase 1 SAD/MAD clinical data, and provide strong support for Biohaven’s plans to initiate pivotal studies with BHV-7000 in focal epilepsy and bipolar disorder in the second half of 2023. The preliminary data highlight BHV-7000’s differentiation and potentially favorable clinical profile compared to other ASMs, and Biohaven expects to present the complete EEG results by the end of the year. Additionally, new pharmacokinetic data from multiple clinical formulations being studied has now confirmed a once daily extended-release formulation that will be used in the Phase 2/3 clinical programs. Biohaven has now successfully dosed three dose cohorts with single ascending doses of its brain penetrant TYK2/JAK1 agent, BHV-8000, in the ongoing Phase 1 study. The ongoing Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of BHV-8000 in healthy volunteers. Based on the preliminary data that are available, projected therapeutic concentrations of BHV-8000 were achieved, and BHV-8000 was well tolerated with only mild adverse events reported. Biohaven anticipates completing enrollment in a Phase 3 study of troriluzole in OCD by the end of the year. Two Phase 3 randomized, double-blind, placebo-controlled studies are expected to enroll up to 700 patients (in each trial) across nearly 200 global study sites.