Biohaven announces ‘positive’ TRAP degrader data

Biohaven (BHVN) highlighted the success of its first MoDE and TRAP degraders in achieving key target pharmacodynamic endpoints and announced plans to initiate pivotal trials in Graves’ Disease and in IgA nephropathy in the second half of 2025 and first half of 2026, respectively, at Biohaven’s 2025 R&D Day, held concurrently with the Yale Innovation Summit in New Haven, Connecticut. “BHV-1400, the Company’s potential first-in-class galactose-deficient IgA1 TRAP degrader for the treatment of IgA nephropathy achieved deep, rapid, and sustained reductions in Gd-IgA1. In the Phase 1 study, a single dose of BHV-1400 was subcutaneously administered at a dose of 500 mg and achieved rapid, deep and sustained reductions in Gd-IgA1 of up to 81%, with a median reduction of 66%. Reductions occurred within hours of each dose, were progressive, and were sustained for weeks after a single dose administration. Effects were selective, with no significant reductions observed in other immunoglobulins: IgA, IgG, IgE, or IgM… Based upon the rapid and deep reductions of Gd-IgA1 observed with SC dosing of BHV-1400, Biohaven plans to study BHV-1400 in patients with IgAN and initiate pivotal trials in 2026 using UPCR surrogate endpoint via the accelerated approval pathway,” the company stated. Tova Gardin, MD, MPP, Chief Translational Officer at Biohaven, commented, “Our lead MoDE and TRAP degraders, BHV-1300 and BHV-1400, deliver on the promise of ground-breaking chemistry, demonstrating unrivaled selectivity, and profound depletion of potentially disease-causing proteins. With the selectivity of the platform and the initial profile observed in Phase 1, we aim to bring precision immunology to patients with safe and effective treatments that target the core of disease biology. We are incredibly proud of our innovative, agile, and dynamic team that has catalyzed a first of its kind extracellular degrader technology from bench to the clinic. Driven by patient need and leading-edge, mechanistically precise science, Biohaven remains focused on delivering the promise of precision therapies to patients with immune-mediated disease.”