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

About this update from Roivant Sciences Ltd.

Pivotal study in MG met primary endpoint of change from baseline in MG-ADL in AChR+ population at 12 weeks, with a 5.6 point improvement in the higher dose arm (with 74% mean IgG reduction) and a 4.7 point improvement in the lower dose arm (with 64% mean IgG reduction) Initial CIDP results from Period 1, following standard of care washout, demonstrate a mean improvement in the adjusted INCAT disability score of 1.8 across batoclimab arms and an 84% responder rate in those patients who achieved an IgG lowering greater than 70% In both batoclimab studies, deeper IgG reductions correlated with better clinical outcomes across a range of assessments and timepoints INDs active for both MG and CIDP with pivotal study initiations for lead asset IMVT-1402 in these indications expected imminently Immunovant and Roivant to host combined investor call to discuss these updates today, March 19, 2025 at 8 a.m. EDT NEW YORK , March 19, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT) , a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported topline results from its Phase 3 study of batoclimab in MG and initial results from Period 1 of its Phase 2b study in CIDP. “We are excited to share positive results from our MG and CIDP studies. While neurologists and patients are very enthusiastic about currently approved FcRn inhibitors, they tell us that they also see a lot of potential for a next-generation FcRn inhibitor that can offer deeper and more durable responses for patients whose disease is still affecting their daily function. Today’s results show that deeper IgG reduction leads to deeper responses in MG and CIDP. Beyond the results in MG and CIDP, we believe that our core thesis - that deeper IgG reduction, at the levels achieved by high dose batoclimab and high dose IMVT-1402, leads to improved clinical outcomes - will apply to a wide range of auto-antibody mediated conditions,” said Pete Salzmann , M.D., chief executive officer of Immunovant. About the Phase 3 Study in MG The Phase 3 study in MG is a randomized, quadruple-blind, placebo-controlled study designed to assess the efficacy and safety of batoclimab in adults with MG. Following screening, participants with moderate to severe MG were randomized into Period 1 where they received high dose batoclimab (680mg weekly) or lower dose batoclimab (340mg weekly) or placebo for 12 weeks. Responders to batoclimab in Period 1, defined as ≥2-point improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline, were re-randomized 1:1:1 to batoclimab (340mg weekly or 340mg every other week) or placebo for 12 weeks (Period 2). The primary endpoint of the study was mean change from baseline in MG-ADL in acetylcholine receptor antibody positive (AChR+) participants at Week 12 (end of Period 1). About the Phase 2b Study in CIDP The Phase 2b study in CIDP is a randomized, quadruple-blind, placebo-controlled study designed to assess the efficacy and safety of batoclimab in adult participants with active CIDP. Similar to other recent studies, this Phase 2b study in CIDP begins with a non-placebo controlled run-in (Period 1), during which participants whose disease had worsened during standard of care washout then receive either 340 mg or 680 mg batoclimab weekly by subcutaneous injection. Participants who respond to batoclimab therapy in Period 1 (responders are defined as those achieving a ≥1 point improvement from Period 1 baseline in adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score), are then randomized 1:1 to receive either 340 mg batoclimab or placebo weekly in a 24-week withdrawal period (Period 2). The primary endpoint will assess the percentage of participants who remain relapse-free at Week 36, at the end of Period 2. The study is ongoing and has not yet been unblinded. Therefore, pooled data are currently available from Period 1 and no data are available for the primary endpoint at the end of Period 2. Phase 3 MG Study Results Highlights In the Phase 3 MG study, batoclimab met its primary endpoint of mean change from baseline in MG-ADL in AChR+ participants. Participants entering the study and randomized to 680mg of batoclimab given weekly by subcutaneous injection achieved a 5.6 point improvement in MG-ADL at Week 12, while those randomized to 340mg of batoclimab given weekly by subcutaneous injection achieved a 4.7 point improvement in MG-ADL at Week 12 and those randomized to placebo experienced a 3.6 point improvement in MG-ADL at Week 12. Large differences between the dosing arms were observed, especially for deeper response thresholds. Results in Period 2 (Weeks 12-24) were as expected, with patients re-randomized to 340mg weekly outperforming those whose dose was reduced. Additional efficacy results are summarized in the table below: Snapshot of Efficacy Measures Observed Placebo Batoclimab 340mg Batoclimab 680mg (% AChR+ Population) (QW)^ (QW)^^ Minimal Symptom Expression (MSE*) at Wk 12 7% 31% 42% Durable MSE** 0% 39% 75% Early Super Responders (≥5 point reduction in MG-ADL score by Wk 2) 11% 25% 40% Early Super Responders (≥6 point reduction in MG-ADL score by Wk 2) 6% 17% 30% Early Super Responders (≥7 point reduction in MG-ADL score by Wk 2) 2% 10% 19% ^ all p

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