On March 19, 2025, Immunovant, a clinical-stage immunology company and part of Roivant Sciences, reported positive topline results from its Phase 3 study of batoclimab in Myasthenia Gravis (MG). Batoclimab met its primary endpoint, with participants receiving 680mg weekly achieving a 5.6 point improvement in MG-ADL at Week 12, compared to a 3.6 point improvement for placebo. This demonstrates significant efficacy in treating MG.
Initial results from Period 1 of the Phase 2b study in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) also showed positive outcomes. Pooled batoclimab data from 73 patients demonstrated a 1.8 point improvement in aINCAT at Week 12, with an 84% responder rate among patients whose IgG was reduced by 70% or more. Safety and tolerability profiles were consistent with prior batoclimab studies for both indications.
Despite these positive results, Immunovant plans to initiate potentially registrational studies in both MG and CIDP with its lead asset, IMVT-1402, rather than batoclimab. This strategic decision is based on the anticipation that IMVT-1402 may deliver deeper and more durable clinical responses due to its potential for superior IgG reduction. Immunovant will await results from ongoing Phase 3 studies of batoclimab in Thyroid Eye Disease before making a final decision on regulatory submissions for batoclimab.
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