Immunovant ends CLE study of IMVT-1402

• Immunovant (NASDAQ:IMVT) reported that IMVT-1402 did not meet the primary endpoint in a Phase 2 proof-of-concept trial for cutaneous lupus erythematosus.
• The company plans to stop development of IMVT-1402 in CLE despite numerical trends favoring the treatment on several measures.
• Immunovant said IMVT-1402 development programs in other autoimmune diseases remain on track.

Immunovant (NASDAQ:IMVT) reported topline results from Period 1 of its proof-of-concept trial of IMVT-1402 in cutaneous lupus erythematosus, with the study failing to meet its primary endpoint.

The trial did not achieve statistical significance for the percent change from baseline in CLASI-A score at Week 12, and Immunovant said the results did not meet its internal criteria to continue development in CLE.

The company reported numerical trends favoring IMVT-1402 over placebo across multiple endpoints, with deeper IgG reductions associated with improved clinical responses.

IMVT-1402 showed a favorable safety and tolerability profile consistent with previous studies, according to Immunovant, and no changes were announced for other autoimmune disease programs.

Immunovant said development timelines for IMVT-1402 in Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease remain on track.