Biohaven reports clinical, regulatory milestones across MoDE platform

Biohaven (BHVN) highlighted the achievement of several clinical and regulatory milestones across its proprietary Molecular Degrader of Extracellular Proteins, MoDE, platform as well as its glutamate modulation and ion channel programs. Subcutaneously administered BHV-1300 achieved deep lowering of targeted IgG, with reductions greater than 60% in the lowest subcutaneous dose tested in the ongoing multiple ascending dose study. Subcutaneous BHV-1300 achieved progressive reduction in IgG within hours of each weekly dose administration in the MAD, and pharmacodynamic effects were sustained relative to baseline over the four-week study period. BHV-1300 has been safe and well-tolerated across the Phase 1 study. There were no clinically significant effects on albumin or liver function, and no increases in cholesterol were noted. In addition to the new Phase 1 data with BHV-1300, Biohaven also announced regulatory acceptance of three INDs and/or CTAs for its next-generation MoDE molecules to target other immune mediated diseases. Two of these novel MoDEs, BHV-1400 and BHV-1600, represent the platform’s first autoantibody specific degraders, sparing the body’s healthy antibodies to function normally while clearing disease-causing antibodies. Dosing in humans has been initiated for BHV-1400, a novel IgA nephropathy investigational therapy designed to selectively degrade galactose deficient IgA1 without immunosuppression. Biohaven also initiated dosing in humans with BHV-1600 in 4Q 2024.