Roivant Sciences Ltd. (ROIV) announced that Immunovant Inc. (IMVT) plans to halt the development of IMVT-1402 as a treatment for cutaneous lupus erythematosus (CLE).

The decision follows recent proof-of-concept trial results that failed to reach statistical significance. Shares of both Immunovant and Roivant Sciences fell following the announcement.

CLE is a chronic autoimmune skin condition where the immune system attacks skin cells, causing rashes and sores mostly on sun-exposed areas.

Trial Misses Primary Endpoint

During Period 1 of the trial, IMVT-1402 did not achieve its primary goal. The study measured the percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12.

While the drug missed the main target, researchers observed positive numerical trends favoring the treatment over a placebo.

Patients who experienced deeper IgG reductions from their baseline showed better clinical outcomes.

Additionally, the drug maintained a favorable safety and tolerability profile consistent with earlier studies.

Shifting Focus To Other Autoimmune Diseases

Despite these positive safety trends, the clinical outcomes and the current competitive landscape prompted the company to stop further CLE development.

The data ultimately did not meet the internal bar required to justify continuing the program.

Immunovant will concentrate on rapidly advancing IMVT-1402 for other autoimmune conditions with significant unmet needs.

These targeted diseases include Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren's disease.

Price Action: Immunovant shares were down 6.11% at $35.01 and Roivant Sciences shares were down 2.93% at $37.10 during premarket trading on Wednesday, according to market data.