Immunovant Reports Positive Phase 3 and Phase 2b Results for Batoclimab in Myasthenia Gravis and CIDP

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The company recently announced positive topline results from its phase 3 study in patients with MG and initial data from its phase 2b study in patients with CIDP, both assessing batoclimab.

Pete Salzmann, MD, MBA

(Credit: LinkedIn)

Immunovant has reported promising topline results from its phase 3 study (NCT05403541) of investigational batoclimab in myasthenia gravis (MG) and initial results from Period 1 of its phase 2b study (NCT05581199) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Findings showed that treatment with the therapy resulted in significant improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores and a robust response rate among patients with CIDP, with both trials showing favorable safety profiles of the drug.¹

In the phase 3 study of batoclimab in MG, the investigational therapy met its primary end point of improvement in MG-ADL scores in acetylcholine receptor antibody positive (AChR+) participants. All told, those receiving the 680 mg weekly dose saw a 5.6-point improvement, while the 340 mg dose group showed a 4.7-point improvement at Week 12, compared with a 3.6-point improvement in the placebo group. The phase 2b CIDP study (NCT05581199) also produced encouraging early data, showing a 1.8-point improvement in adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) scores and a high 84% responder rate in patients with at least 70% IgG reduction after 12 weeks.

“We were very encouraged by the magnitude of the treatment results observed with the FcRn inhibition [in the trials], [in particular] in the placebo controlled portion of the MG trial," Pete Salzmann, MD, MBA, chief executive officer at Immunovant, told NeurologyLive^® in a recent interview. “While neurologists and patients are enthusiastic about currently approved FcRn inhibitors, we believe they also see a potential for an FcRn inhibitor that can offer deep and durable responses for patients whose disease is still affecting their daily function”.

The phase 3 MG study was a randomized, quadruple-blind, placebo-controlled trial designed to assess the efficacy and safety of batoclimab in adults with moderate to severe MG. The primary end point—mean change from baseline in MG-ADL in AChR+ participants—was met, with both dose groups demonstrating significant improvements over placebo. Participants who responded to the high-dose treatment were re-randomized to either a lower-dose or placebo for a further 12 weeks, with the high-dose cohort continuing to outperform the placebo group.

In the phase 2b CIDP study, batoclimab demonstrated significant clinical benefits during the initial 12-week run-in phase. Participants treated with the agent showed meaningful improvements across multiple scales, including a 15.3-point improvement in the Inflammatory Rasch-built Overall Disability Scale (I-RODS), 5.6-point improvement in Medical Research Council Sum Score (MRC-SS), and a 15.1 improvement in grip strength. The responder rate for patients with at least 70% IgG reduction was 84%, underscoring the potential of batoclimab in CIDP management.

The safety and tolerability of batoclimab in both studies were consistent with previous trials, with no new safety concerns reported. Immunovant has indicated that it does not plan to seek regulatory approval for batoclimab in MG or CIDP but will use the data from these studies to inform its ongoing work with its next-generation FcRn inhibitor, IMVT-1402. With these positive early results, Immunovant is poised to advance IMVT-1402, which could offer deeper and more durable responses for patients with autoimmune diseases like MG and CIDP. The company plans to continue its studies, including ongoing research into batoclimab in thyroid eye disease, to shape the future of treatments in this space.

REFERENCES
1. Immunovant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies. News Release. Immunovant. Published March 19, 2025. Accessed March 19, 2025. https://www.immunovant.com/investors/news-events/press-releases/detail/71/immunovant-announces-positive-results-for-batoclimab