envudeucitinib (ESK-001) - (LUMUS)

September 1, 2026: Alumis (NASDAQ: ALMS) reported that the Phase 2b LUMUS trial (NCT05966480) of envudeucitinib in moderate-to-severe systemic lupus erythematosus did not meet its primary endpoint (BICLA at Week 48) or secondary endpoints in the overall population. The randomized, double-blind, placebo-controlled study enrolled 408 autoantibody-positive SLE patients treated for 48 weeks.

In a prespecified IFNGS-high subgroup, envudeucitinib showed robust responses on BICLA and key secondary measures including CLASI-50, SRI-4, and LLDAS. The company said IFNGS-high patients were under-represented in LUMUS, which reduced response rates in the overall population, and plans regulatory engagement to discuss Phase 3 development in SLE.

Pharmacodynamic data showed dose-dependent interferon-pathway target engagement, with maximal suppression at 40 mg twice daily. Envudeucitinib was generally well tolerated, with no new safety signals.

Separately, Alumis said it remains on track to submit an NDA for envudeucitinib in moderate-to-severe plaque psoriasis in 4Q 2026, following previously reported positive Phase 3 ONWARD results. The company also cited potential future development in interferon-driven diseases including cutaneous lupus erythematosus and Sjögren’s disease.