Biohaven Initiates Phase 3 Trial of First MoDE Degrader for Graves’ Disease
BHVN•Biohaven enrolled the first patient in its pivotal Phase 3 trial of BHV-1300, the first MoDE extracellular protein degrader targeting the TSHR-IgG1 autoantibody driving Graves’ disease. Phase 1b data showed over 80% reduction in pathogenic antibodies, rapid normalization of thyroid hormones and favorable tolerability.
1. Phase 3 Trial Launch
Biohaven has enrolled the first patient in a randomized, double-blind, placebo-controlled Phase 3 pivotal trial of BHV-1300 in approximately 300 adults with Graves’ disease, aiming to restore normal thyroid function at 26 weeks without antithyroid drugs.
2. Promising Phase 1b Data
In the Phase 1b expansion, weekly 1,000 mg subcutaneous doses of BHV-1300 achieved over 80% reduction in pathogenic TSHR-IgG1 autoantibodies, led to rapid normalization of free T4 and free T3, and demonstrated favorable safety and tolerability.
3. MoDE Platform and Pipeline
BHV-1300 is the lead molecule from Biohaven’s MoDE™ extracellular protein degrader platform, exclusively licensed from Yale, designed to selectively clear disease-driving IgG1, 2 and 4 antibodies while sparing other immunoglobulin subclasses.
4. Unmet Need in Graves’ Disease
Graves’ disease affects roughly 1% of the global population and has had no new targeted therapies in over 70 years; current treatments suppress thyroid function or destroy the gland without addressing the underlying autoimmune cause.
