Immunovant reports batoclimab clinical studies missed primary endpoint

Immunovant (IMVT) reported the topline results from its two Phase 3 clinical studies evaluating batoclimab as an investigational treatment for adults with active, moderate-to-severe thyroid eye disease. Based on the pre-specified statistical analysis plan, the studies failed to meet their primary endpoint of 2mm proptosis responder rate at Week 24, following 12 weeks of high-dose and 12 weeks of low-dose batoclimab treatment. Safety results were consistent with previous findings, and no new safety signals were identified. Patients in the TED studies had greater levels of proptosis improvement from baseline after the initial 12-week high-dose period than after the following 12-week low-dose period, supporting the benefit of deeper IgG suppression. The subset of hyperthyroid patients in the TED studies showed similar response rates of thyroid hormone normalization to those seen in the batoclimab Phase 2 study in Graves’ disease. Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402, an investigational FcRn blocker, across multiple autoimmune diseases with significant unmet need, with Graves’ disease as a key strategic priority. Recent Phase 2 proof-of-concept data highlighted FcRn blockade as a potentially disease-modifying approach in Graves’ disease. Topline data from the potentially registrational studies of IMVT-1402 in Graves’ disease are expected in calendar year 2027. Immunovant intends to review future plans for the development of batoclimab with its partner HanAll Biopharma and to provide an update on the program, in conjunction with HanAll, at a future date.