Experimental skin lupus therapy dropped after trial misses main goal
Week 12 CLASI-A endpoint was not statistically significant versus placebo
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After a proof-of-concept clinical trial failed to meet its main goal, Immunovant announced that it will not pursue further development of its experimental therapy IMVT-1402 (imeroprubart) as a treatment for cutaneous lupus erythematosus (CLE).
Immunovant sponsored a Phase 2 study (NCT06980805) that compared IMVT-1402 with a placebo in 57 adults with CLE, a form of lupus primarily characterized by skin problems.
The study, which took place in the U.S. and several other countries, showed that IMVT-1402 did not significantly outperform placebo on the primary endpoint, the percent change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12.
Some trial measures favored IMVT-1402 over placebo
In a company press release, Immunovant said that there were “numerical trends favoring IMVT-1402 over placebo … across multiple endpoints,” with better clinical responses among patients who had greater reductions in IgG antibody levels following treatment.
But despite some encouraging trends, the results did not meet Immunovant’s internal bar for continuing development of IMVT-1402 in CLE. Citing the clinical results and the competitive landscape, Immunovant said it plans to stop developing IMVT-1402 for CLE.
“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, MD, CEO of Immunovant.
Lupus is an autoimmune disease driven by antibodies that mistakenly attack the body’s own tissues. IMVT-1402 is designed to block the activity of neonatal Fc receptor (FcRn), a protein that normally helps prevent IgG antibodies from being broken down. By inhibiting FcRn, the experimental therapy aims to lower IgG levels, including harmful autoantibodies. IMVT-1402 is given by injection under the skin, or subcutaneously.
Although Immunovant will no longer develop IMVT-1402 for CLE, the company is continuing to develop the experimental therapy for a range of other antibody-driven autoimmune diseases, such as Sjögren’s disease and myasthenia gravis. Referring to the patients and investigators who took part in the CLE study, Venker said, “Their contributions advance our understanding of FcRn inhibition in autoimmune disease and will inform our work going forward.”
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