Immunovant, Inc. today reported positive top-line results from its Phase 3 study of batoclimab in Myasthenia Gravis (MG) and initial Period 1 results from its Phase 2b study in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). In the Phase 3 MG study, batoclimab met its primary endpoint, with the 680mg weekly dose achieving a 5.6-point improvement in MG-ADL at Week 12 in AChR+ participants, compared to a 3.6-point improvement for placebo. The 340mg weekly dose showed a 4.7-point improvement.
Initial data from Period 1 of the Phase 2b CIDP study, pooling 73 patients, demonstrated a 1.8-point improvement in aINCAT at Week 12. An 84% responder rate was observed among patients who achieved at least a 70% reduction in IgG levels. In both studies, deeper IgG reductions correlated with improved clinical outcomes across various assessments.
Despite these positive results, Immunovant stated it does not intend to seek regulatory approval for batoclimab in MG or CIDP. Instead, the company will leverage the data and learnings from these batoclimab studies to inform and accelerate its programs with its lead asset, IMVT-1402, for which Investigational New Drug (IND) applications have already been cleared for both MG and CIDP. This strategic decision underscores Immunovant's focus on IMVT-1402 as a potentially best-in-class anti-FcRn inhibitor.
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