Roivant Sciences(ROIV) GlobeNewswire·2025-03-19 11:45Core 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] - The primary endpoint was the mean change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 12, with significant improvements observed in both dosing arms [8] - The higher dose (680mg weekly) achieved a 5.6 point improvement in MG-ADL with a 74% mean IgG reduction, while the lower dose (340mg weekly) showed a 4.7 point improvement with a 64% mean IgG reduction [7][8] Phase 2b Study in CIDP - The Phase 2b study is also a randomized, quadruple-blind, placebo-controlled trial designed to evaluate batoclimab's efficacy and safety in active CIDP [4] - Initial results from Period 1 indicated 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 greater than 70% [9] Efficacy and Safety Results - In the MG study, deeper IgG reductions correlated with better clinical outcomes across various assessments [7] - Safety and tolerability profiles were consistent with previous batoclimab studies, indicating a favorable safety profile [10] 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 [11] - 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 [12]