Biohaven Shows Early Clinical Gains in Graves’ Disease and IgAN

Biohaven reports Phase 1b data for BHV‑1300 and BHV‑1400, showing rapid biomarker and clinical improvements in Graves’ disease and IgA nephropathy. Pivotal trials are planned for 2026.

Biohaven Ltd. unveiled new Phase 1b patient data for its extracellular degrader platforms, MoDE™ and TRAP™, during its R&D and Analyst Day at the 2026 Yale Innovation Summit. The results highlight encouraging biomarker and early clinical improvements in Graves’ disease and IgA nephropathy (IgAN), supporting pivotal studies later this year for BHV-1300 and BHV-1400.

BHV-1300: Rapid Hormone Normalization in Graves’ Disease

In Graves’ hyperthyroidism, Biohaven’s lead MoDE degrader BHV-1300 (NCT06980649) reduced pathogenic TSH receptor IgG1 (TSHR-IgG1) antibodies by more than 80% at week 12 with weekly 1000 mg dosing. Thyroid hormone levels normalized rapidly, with median free T4 normalization within three weeks and free T3 within five weeks. Patients reported improvements in hallmark hyperthyroid symptoms including palpitations, tremor, fatigue, diarrhea, diaphoresis, and mood disturbances.

The therapy was well tolerated, with no serious adverse events, no discontinuations, and only mild, self-limiting side effects. Unlike FcRn inhibitors, BHV-1300 preserved IgG3 while selectively lowering disease-associated IgG subclasses and avoided clinically meaningful increases in cholesterol or liver enzymes. Graves’ disease remains a major unmet need, with no FDA-approved disease-modifying therapy introduced in over 70 years.

BHV-1400: TRAP Platform Shows IgAN Biomarker Impact

Biohaven also presented early Phase 1b data for BHV-1400 (NCT07054684), its first TRAP extracellular degrader. The therapy reduced galactose-deficient IgA1 (Gd-IgA1), the key pathogenic driver of IgAN, by more than 60% within 48 hours and approximately 70% after one month of dosing.

Biomarker reductions correlated with resolution of hematuria, lower urine protein-creatinine ratio (UPCR), and improved estimated glomerular filtration rate (eGFR). Patients also reported reduced fatigue. BHV-1400 demonstrated a favorable safety profile, with no serious or severe adverse events and no clinically significant reductions in protective immunoglobulins including IgG, IgA, IgE, and IgM.

 Precision Strategy Versus Broad Immunosuppression

Biohaven’s extracellular degrader approach differs from conventional immunosuppressive therapies by selectively eliminating pathogenic antibodies while preserving protective immunity. The precision approach may improve long-term safety while maintaining efficacy in chronic autoimmune diseases.

Regulatory Path Ahead

Biohaven plans to initiate a pivotal placebo-controlled Phase 3 trial for BHV-1300 in Graves’ disease within weeks. The study will evaluate normalization of T3, T4, and TSH at 26 weeks without antithyroid drugs.

A pivotal IgAN study for BHV-1400 is expected to begin in mid-2026, with one-year UPCR and eGFR outcomes intended to support regulatory approval.

Reference

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves’ Disease and IgA Nephropathy | Biohaven, Ltd.