Immunovant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies

Core Insights - Immunovant, Inc. reported positive topline results from its Phase 3 study of batoclimab in Myasthenia Gravis (MG) and initial results from its Phase 2b study in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [1][2] Phase 3 Study in MG - The Phase 3 study was a randomized, quadruple-blind, placebo-controlled trial assessing batoclimab's efficacy and safety in adults with moderate to severe MG [3] - Participants receiving 680mg of batoclimab weekly achieved a 5.6 point improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 12, while those on 340mg achieved a 4.7 point improvement [6][7] - The study met its primary endpoint with a significant mean change from baseline in MG-ADL for acetylcholine receptor antibody positive (AChR+) participants [6] Phase 2b Study in CIDP - The Phase 2b study is also a randomized, quadruple-blind, placebo-controlled trial designed to evaluate batoclimab in adults with active CIDP [4] - Initial results from Period 1 showed a mean improvement of 1.8 points in the adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score, with an 84% responder rate among patients achieving an IgG reduction of ≥70% [8] - Other scales demonstrated improvements, including a 15.3 point increase in I-RODS, a 5.6 point increase in MRC-SS, and a 15.1 increase in grip strength at Week 12 [8] Efficacy and Safety - Deeper IgG reductions correlated with better clinical outcomes across both studies [6][8] - Safety and tolerability profiles were consistent with previous batoclimab studies [9] Future Plans - Immunovant plans to initiate potentially registrational studies for both MG and CIDP with its lead asset IMVT-1402, having received clearance for Investigational New Drug (IND) applications [10] - The company does not intend to seek regulatory approval for batoclimab in MG or CIDP at this time, focusing instead on leveraging data from these studies to inform its programs with IMVT-1402 [11]