Immunovant’s Phase 3 Batoclimab Trials Fail ≥2 mm Proptosis Endpoint, Show High-Dose Benefit
Immunovant’s Phase 3 batoclimab trials in moderate-to-severe thyroid eye disease failed to meet the ≥2 mm proptosis responder rate at Week 24 after 12 weeks high- and low-dose treatment. Patients had greater proptosis improvement during the high-dose period, hyperthyroid subsets matched Phase 2 Graves’ disease hormone normalization rates, and no new safety signals emerged.
1. Phase 3 Trial Outcomes
Immunovant conducted two identical Phase 3 studies evaluating batoclimab in adults with active, moderate-to-severe thyroid eye disease. Both studies failed to achieve the pre-specified ≥2 mm proptosis responder rate at Week 24 following 12 weeks of high-dose and 12 weeks of low-dose administration.
2. Dose-Response Observations
Patients experienced greater proptosis reduction during the initial 12-week high-dose period compared with the subsequent low-dose period, underscoring the benefit of deeper IgG suppression for maximal clinical response.
3. Safety Profile Assessment
Safety findings mirrored earlier trials, with no unexpected adverse events or new safety signals identified across both dosing regimens, reaffirming batoclimab’s established tolerability profile.
4. Future Development Strategy
Immunovant will collaborate with HanAll Biopharma to reassess batoclimab’s development path while accelerating IMVT-1402 across multiple autoimmune indications, targeting potential Phase 2 registration data in Graves’ disease by 2027.