Roivant Sciences (NASDAQ:ROIV) said its majority-owned subsidiary Immunovant will discontinue development of IMVT-1402, also known as imeroprubart, in cutaneous lupus erythematosus after a proof-of-concept study failed to meet its primary endpoint.
The randomised, double-blind, placebo-controlled trial enrolled 57 adults with cutaneous lupus erythematosus.
Its primary endpoint measured the percentage change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity, or CLASI-A, score at Week 12. The study did not achieve statistical significance on that measure.
Immunovant to End Development in CLE
Immunovant said it plans to stop development of IMVT-1402 for cutaneous lupus erythematosus based on the clinical results and the competitive landscape.
According to the company, numerical trends favouring IMVT-1402 over placebo were observed across several endpoints. It also reported that patients who achieved greater reductions in immunoglobulin G, or IgG, levels were more likely to show improved clinical responses.
The company said the safety and tolerability profile of IMVT-1402 in the trial was consistent with previous studies.
“On behalf of everyone at Immunovant, I want to thank the patients living with CLE who volunteered for this study and the investigators and clinical site teams who conducted it with such care,” said Eric Venker, M.D., Pharm.D., Chief Executive Officer of Immunovant.
Development Continues in Other Autoimmune Diseases
The decision does not affect Immunovant’s development of IMVT-1402 in other autoimmune indications.
The drug remains in clinical development for Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease.
Immunovant said timelines for its other clinical development programmes remain on track.
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