Alumis eyes late-stage lupus study despite trial miss
Alumis said the drug was well tolerated and showed strong results in a subgroup with high interferon activity, supporting a planned Phase 3 discussion.
- On Tuesday, Alumis announced its experimental drug envudeucitinib failed to meet its primary endpoint in a mid-stage trial involving 408 adults with systemic lupus erythematosus, though the company plans to pursue a Phase 3 trial.
- Company shares plummeted nearly 55% following the results, erasing almost all stock gains this year, as Wall Street had viewed the study as a critical test in a notoriously difficult disease category.
- Patients with a "high interferon gene signature" showed "robust" responses, according to Alumis, representing a smaller population share than anticipated but supporting continued development.
- Envudeucitinib is a TYK2 inhibitor, a class popularized by Bristol Myers Squibb's Sotyktu; Takeda Pharmaceuticals invested $4 billion in a similar candidate, though prior blockers struggled outside psoriasis.
- CEO Martin Babler affirmed the company remains on track to file for U.S. regulatory approval of envudeucitinib for psoriasis by late 2026, despite Stifel analyst Alex Thompson calling the lupus results "disappointing.
12 Articles
12 Articles
Alumis Inc. (ALMS) Discusses Phase IIb LUMUS Trial Results and Subgroup Insights in Type 1 Interferon-Driven Diseases Transcript
Alumis Inc. (ALMS) Discusses Phase IIb LUMUS Trial Results and Subgroup Insights in Type 1 Interferon-Driven Diseases September 1, 2026 8:30 AM EDTCompany...
Alumis Lupus Trial Misses Main Goals, but High-Interferon Subgroup Shows Promise
Alumis (NASDAQ:ALMS) said its Phase II LUMUS trial of envudeucitinib in systemic lupus erythematosus, or SLE, did not meet its primary or key secondary endpoints in the overall study population. However, the company said pre-specified analyses showed clinically meaningful responses among patients wi
Alumis’ lupus drug heads to Phase III despite mid-stage miss
California-based biopharma company Alumis is taking its immunology candidate, envudeucitinib, to Phase III in a type of lupus, despite the drug missing its goals across the general population in a Phase IIb trial. During the mid-stage LUMUS study (NCT05966480), Alumis pitted three different doses…
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