Immunovant said it saw negative topline results from Period 1 of its proof-of-concept trial evaluating IMVT-1402 imeroprubart for the treatment of cutaneous lupus erythematosus.
The company said the study didn't achieve statistical significance on its primary endpoint of percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity score at Week 12.
Immunovant said numerical trends favoring IMVT-1402 over placebo were observed across multiple endpoints, and patients who achieved deeper IgG reductions from baseline were more likely to achieve improved clinical responses. However, due to the competitive landscape and the clinical results observed, Immunovant plans to stop development in CLE.
The company said it will still focus on advancing the clinical development of IMVT-1402 across multiple autoimmune diseases, including Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren's disease.
The proof-of-concept clinical study of IMVT-1402 in CLE was a randomized, double-blind, placebo-controlled, global trial that assessed the safety and efficacy of IMVT-1402 in adult patients with CLE. The study enrolled 57 patients. In Period 1, patients were randomized to IMVT-1402 versus placebo for a 12-week treatment period.
The stock was down 5% at $35.54 in mid-morning trade, but is 138% higher in the past 12 months.
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