Alumis SLE trial fails primary endpoints; subgroup data guides Phase 3

Alumis Inc. (Nasdaq: ALMS) announced that its Phase 2b LUMUS trial of envudeucitinib for moderate-to-severe systemic lupus erythematosus (SLE) did not meet its primary and secondary endpoints in the overall trial population, according to a company statement.

The trial enrolled 408 patients who received one of three envudeucitinib doses or placebo over 48 weeks. The primary endpoint measured overall disease activity using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 48.

A prespecified subgroup of patients with high interferon gene signature (IFNGS-high) showed responses on the primary endpoint and key secondary measures, including CLASI-50, SRI-4, and Lupus Low Disease Activity State. Alumis said IFNGS-high patients were unexpectedly under-represented in the trial, which it cited as a factor reducing response rates in the overall population.

"Although envudeucitinib did not meet its primary objective in the overall trial population, the magnitude of effect observed in the prespecified IFNGS-high subgroup is highly compelling in a disease with no targeted oral therapies currently available," said Dr. Jörn Drappa, Chief Medical Officer of Alumis. "We plan to engage regulators to discuss Phase 3 development for envudeucitinib."

Pharmacodynamic data from the trial showed dose-dependent interferon-pathway target engagement, with maximal suppression at the 40mg twice-daily dose. The company reported no new safety signals.

Alumis said it remains on track to submit a New Drug Application (NDA) for envudeucitinib in moderate-to-severe plaque psoriasis in the fourth quarter of 2026, following previously reported positive Phase 3 results from its ONWARD program.

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