Immunovant Shares Fall After Lupus Drug Fails to Meet Primary Endpoint in Trial

Shares of Immunovant (NASDAQ: IMVT) fell by 6% in Monday trading after the biotechnology company announced that its experimental drug, IMVT-1402, failed to meet the primary goal in a study for cutaneous lupus erythematosus (CLE).

Trial Misses Key Endpoint

Immunovant reported that its proof-of-concept study of IMVT-1402, also known as imeroprubart, did not achieve statistical significance on its primary endpoint. The goal was to measure the percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity score at Week 12.

The company stated that the results did not meet its internal criteria to advance the drug for this specific condition. Citing the clinical results and the competitive landscape, Immunovant has decided to discontinue the development of IMVT-1402 for the CLE indication.

Study Details and Outlook

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The randomized, double-blind, placebo-controlled trial involved 57 adult patients. While the primary objective was not met, Immunovant noted that it observed numerical trends favoring its drug over the placebo across multiple endpoints. The company also said that patients who achieved deeper reductions in IgG antibodies were more likely to show improved clinical responses.

Despite the setback, the drug demonstrated a favorable safety and tolerability profile, consistent with previous studies. Immunovant confirmed that all other clinical development timelines for IMVT-1402 remain on track. The company continues to develop the drug for several other autoimmune diseases, including:

• Graves’ disease
• Rheumatoid arthritis
• Myasthenia gravis
• Chronic inflammatory demyelinating polyneuropathy (CIDP)
• Sjogren’s disease