Immunovant halts CLE development after IMVT-1402 trial misses goal

Immunovant (Nasdaq: IMVT) announced that its proof-of-concept trial of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE) failed to achieve statistical significance on its primary endpoint, and the company will discontinue development of the drug in that indication.

The study, a randomized, double-blind, placebo-controlled global trial, enrolled 57 adult patients. The primary endpoint was percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12. The trial did not meet that measure.

Numerical trends favoring IMVT-1402 over placebo were observed across multiple secondary endpoints, and patients who achieved deeper reductions in IgG levels were more likely to show improved clinical responses. The drug demonstrated a safety and tolerability profile consistent with prior studies, according to the company.

Immunovant cited both the clinical results and the competitive landscape as reasons for stopping CLE development. The company said all other clinical development timelines remain on track.

"On behalf of everyone at Immunovant, I want to thank the patients living with CLE who volunteered for this study and the investigators and clinical site teams who conducted it with such care," said Eric Venker, M.D., Pharm.D., Chief Executive Officer of Immunovant.

The company said it plans to continue advancing IMVT-1402 across other autoimmune indications, including Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren's disease.

Immunovant is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). This report is based on a press release issued by the company.

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