Immunovant, a Roivant company, will stop developing IMVT-1402 (imeroprubart) for cutaneous lupus erythematosus (CLE).
The decision followed a 57-patient randomized Phase 2 proof-of-concept study that failed to achieve statistical significance on its primary endpoint:
percentage change in CLASI-A skin-disease activity score at Week 12.
The company reported numerical trends favoring IMVT-1402 on several measures and better responses among patients with deeper IgG reductions, but said the results did not meet its internal bar when considered alongside the competitive landscape.
IMVT-1402 reportedly showed a favorable safety and tolerability profile. Development in other autoimmune indications—including Graves’ disease, myasthenia gravis, CIDP, rheumatoid arthritis and Sjögren’s disease—remains on track.
The announcement pressured Immunovant shares, which were reported down roughly 6% and near three-month lows.
Sources:
Immunovant ends cutaneous lupus program after phase 2 flop
Immunovant drops lupus program after IMVT-1402 miss
Immunovant ditches lupus for multi-hyphenate inflammatory drug after mid-stage miss
Immunovant halts lupus drug development after trial miss By Investing.com
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