Biohaven Ltd. Enrolls First Patient into Phase 2/3 Trial in Early Parkinson's Disease, Targeting Neuroinflammation with Novel Brain-Penetrant TYK2/JAK1 Inhibitor

Published: 2025-05-29 08:36:09 ET BHVN

Published on 05/29/2025 at 08:36

Biohaven Ltd. announced that it has initiated a global Phase 2/3 study of the first-in-clinic, orally-administered, brain-penetrant, and highly selective TYK2/JAK1 inhibitor, BHV-8000, for the treatment of early Parkinson's disease (PD). The pivotal Phase 2/3 study is a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of BHV-8000 at two dose levels (10 mg and 20 mg) relative to placebo in people living with early PD. The innovative trial design includes a time-to-event primary endpoint analysis based on significant change in the MDS-UPDRS Part II, which is accepted by the US Food and Drug Administration (FDA) to support registration.

The study also includes the utilization of first-in-clinic Parkinson's disease composite scales (PARCOMS), which can potentially improve the sensitivity of identifying changes in function that are meaningful to people living with early PD.