Immunovant Discontinues Batoclimab, Focuses on IMVT-1402
Immunovant, Inc. has announced the discontinuation of its batoclimab development program across all indications, following the failure of two Phase 3 clinical studies in thyroid eye disease (TED) to meet their primary endpoints. The company is now fully focused on advancing IMVT-1402 (imeroprubart), a next-generation FcRn inhibitor, which demonstrated deep, dose-dependent IgG reductions of up to 74% in Phase 1 trials with a potentially favorable safety profile. Immunovant is currently progressing IMVT-1402 through six ongoing studies, including potentially registrational trials in Graves' Disease (GD), difficult-to-treat rheumatoid arthritis (D2T RA), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), and Sjögren's disease (SjD), with top-line results for GD trials expected in 2027.
Key Highlights
- Immunovant discontinued batoclimab development after Phase 3 TED trials failed primary endpoints.
- Company is now fully focused on IMVT-1402 (imeroprubart), a potentially best-in-class FcRn inhibitor.
- IMVT-1402 Phase 1 trial showed 63% IgG reduction (300mg) and 74% IgG reduction (600mg) weekly.
- IMVT-1402 aims to achieve approximately 80% IgG reductions with 600 mg weekly dosing.
- Six ongoing IMVT-1402 studies include registrational trials in GD, D2T RA, MG, CIDP, SjD.
- First registrational GD trial (NCT06727604) initiated Dec 2024, with top-line results expected 2027.
- Second registrational GD trial (NCT07018323) initiated June 2025, with top-line results expected 2027.
- D2T RA trial (NCT067544462) enrolled 170 participants, showing 72.7% ACR20 response at Week 16.
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