Biohaven’s investigative selective potassium channel (Kv7.2/7.3) activator has failed to meet the primary endpoint in a phase 2 proof-of-concept trial of in adults with major depressive disorder (MDD).
The oral drug, BHV-7000, failed to reduce depressive symptoms as measured by change in the Montgomery Åsberg Depression Rating Scale (MADRS) over six weeks compared with placebo.
The company considers the depression subgroup analyses as hypothesis generating but based upon strategic prioritization of its portfolio does not plan on additional psychiatric clinical trials to keep resources focused on key priority areas of immunology, obesity and epilepsy in 2026. The decision comes after BHV-7000 also fell short in a phase 3 bipolar mania trial back in March.
Additional analyses are ongoing and Biohaven plans to present the MDD results at an upcoming scientific meeting.
Last month, Biohaven was hit with a CRL from the FDA for its NDA for the once-daily pill, Vyglxia (troriluzole), which treats spinocerebellar ataxia. The company said it was restructuring to reduce its annual direct R&D spend by 60%, which could result in pausing or delaying non-priority programs over the next year to allocate more resources to priority clinical-stage programs.