BHV-1300 is the first MoDE extracellular protein degrader, a novel small molecule IgG1, 2 and 4 degrader that harnesses the body's own clearance machinery to eliminate the IgG1 TSHR autoantibody driving Graves' disease. In over 70 years, no new therapy has been approved for Graves' disease. BHV-1300 is designed to change the treatment landscape for this autoimmune disease.

Beth Emerson, MD, MBA, Executive Medical Director at Biohaven and Lead for the Graves' disease clinical trial, commented, "The enrollment of the first patient in this pivotal trial marks an important moment for the Graves' disease community. For decades, physicians have relied on treatments that either suppress thyroid function or destroy the gland. BHV-1300 represents an opportunity to bring forward a disease modifying therapy, targeting the underlying cause of Graves' disease, thyroid eye disease, and pretibial myxedema rather than addressing the downstream complications."

BHV-1300 is the lead molecule from Biohaven's MoDE platform — exclusively licensed from Yale University where the technology originated in the Spiegel Lab and advanced by the Biohaven discovery and clinical teams — which directs disease-driving proteins to the body's own natural clearance pathways for selective elimination. The Phase 3 program is grounded in Phase 1b data demonstrating:

  • Greater than 80% reduction of pathogenic TSHR autoantibodies
  • Rapid normalization of free T4 and free T3 in patients with Graves' hyperthyroidism
  • Improvements in hallmark symptoms of Graves' disease
  • Preservation of IgG3, IgA, IgM, and IgE
  • Favorable safety and tolerability

BHV-1300 is the first extracellular degrader to reach a pivotal trial, opening the door to an entirely new therapeutic modality in precision immunology.