Immunovant ends IMVT-1402 development for cutaneous lupus after Phase 2b miss

Insider Monkey

Immunovant ended IMVT-1402’s cutaneous lupus program after its Phase 2b trial missed the primary endpoint: no statistically significant placebo difference in Week 12 percent change in CLASI-A score. Five other program timelines are unchanged, the company said.

The company reported positive numerical trends across multiple endpoints. Patients with deeper IgG reductions were more likely to have improved clinical responses, and the drug’s safety and tolerability profile remained favorable. These findings do not establish clinical efficacy.

The five remaining programs target Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjogren's disease. Topline results are expected in 2027 for Graves' disease and myasthenia gravis, and in 2028 for CIDP and Sjogren's. In an open-label rheumatoid arthritis study, Week 16 ACR20, ACR50 and ACR70 response rates were 72.7%, 54.5% and 35.8%; these were not controlled Phase 3 findings. Immunovant reported $797.8 million in cash and equivalents at June-end; management said its current plan provides runway to a potential Graves' disease commercial launch.

#IMVT-1402-cutaneous-lupus-trial #IMVT-1402-Graves-disease-timeline
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