Immunovant’s Batoclimab Excels in Clinical Trials for Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy
The pivotal Phase III study in myasthenia gravis met its primary endpoint with meaningful improvements in MG-ADL across both higher and lower dose arms.
Image Credit: Adobe Stock Images/Lila Patel
Immunovant has shared positive results of its batoclimab in a Phase III clinical trial in myasthenia gravis (MG) and a Phase IIb trial in chronic inflammatory demyelinating polyneuropathy (CIDP).1
In the Phase III MG study, batoclimab demonstrated a meaningful change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) in AChR+ population at week 12, with a 5.6 point improvement in the higher dose arm and a 4.7 point improvement in the lower dose arm, meeting the primary endpoint.
Results from the Phase IIb trial in CIDP were from Period 1 following a standard of care washout. Data from the study show a mean improvement in the adjusted INCAT disability score of 1.8 across batoclimab arms and an 84% responder rate in patients who achieved an IgG lowering greater than 70%.
In a press release, Pete Salzmann, MD, chief executive officer of Immunovant, said: “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.”
While results across both studies were positive, Immunovant stated it does not intend to seek regulatory approval for batoclimab in MG or CIDP. The company will wait to make a final decision on regulatory submissions for batolclimab until it receives results from Phase III studies evaluating the therapy in thyroid eye disease.
Salzmann continued: “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.”
Immunovant also announced it has received clearance for its Investigational New Drug (IND) applications for its lead asset, IMVT-1402, in both MG and CIDP. The company will look to advance its IMVT-1402 program using data gathered from the batoclimab studies.
Reference
1. Immunovant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies. News release. Immunovant. March 19, 2025. Accessed March 19, 2025. https://www.immunovant.com/investors/news-events/press-releases/detail/71/immunovant-announces-positive-results-for-batoclimab
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