Immunovant Shares Fall 6% After IMVT-1402 Lupus Study Misses Primary Endpoint

Immunovant (NASDAQ:IMVT) shares fell 6% on Monday after the company reported that a proof-of-concept study evaluating IMVT-1402 in cutaneous lupus erythematosus did not meet its primary endpoint.

The trial did not achieve statistical significance on its primary endpoint, which measured the percentage change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity score at Week 12.

Immunovant said the results did not meet its internal criteria for continuing development of IMVT-1402, also known as imeroprubart, in cutaneous lupus erythematosus and that it plans to discontinue development for the indication.

Trial Enrolled 57 Patients

The randomised, double-blind, placebo-controlled study enrolled 57 adults with cutaneous lupus erythematosus.

Participants were randomised to receive either IMVT-1402 or placebo during a 12-week treatment period.

According to Immunovant, numerical trends favouring IMVT-1402 over placebo were observed across several endpoints. The company also said patients who achieved greater reductions in immunoglobulin G, or IgG, from baseline were more likely to show improved clinical responses.

However, Immunovant cited both the clinical results and the competitive landscape in deciding not to continue development of the drug for cutaneous lupus erythematosus.

The company said IMVT-1402’s safety and tolerability profile in the study was consistent with previous trials.

Other IMVT-1402 Programmes Continue

Immunovant said timelines for its other clinical development programmes remain on track.

The company continues to evaluate IMVT-1402 across several autoimmune diseases, including Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease.

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