Alumis' LUMUS trial misses main goals in lupus, but subgroup shows benefit

Alumis Inc. said on September 1, 2026 that its Phase 2b LUMUS trial of envudeucitinib for moderate-to-severe systemic lupus erythematosus did not meet its primary and secondary endpoints in the overall trial population.¹ Despite the miss, the company said key insights from the trial support a clear path forward for regulatory engagement on Phase 3 development.¹

The trial did show robust clinical responses in a prespecified subgroup of patients with high interferon gene signature (IFNGS-high), including on the primary endpoint BICLA and on secondary measures such as CLASI-50, SRI-4, and LLDAS.¹ Alumis noted that IFNGS-high patients typically respond more favorably to interferon-targeted therapies and were unexpectedly under-represented in LUMUS, which reduced response rates across the full study population.¹

On the trial's design, Alumis explained that the global, randomized, double-blind, placebo-controlled study (NCT05966480) tested three doses of envudeucitinib against placebo over 48 weeks in Part A, with 408 total patients, and used BICLA at Week 48 as the primary endpoint.¹

On safety, the company reported that pharmacodynamic data showed dose-dependent interferon-pathway engagement, with the strongest suppression at the 40mg twice-daily dose, and that envudeucitinib was well tolerated with no new safety signals.¹

Chief Medical Officer Jörn Drappa said the company plans to engage regulators on Phase 3 development given the subgroup results, according to the release. Separately, Alumis said it remains on schedule to file a New Drug Application for envudeucitinib in moderate-to-severe plaque psoriasis before the end of 2026, a plan CEO Martin Babler reiterated alongside comments on evaluating the broader TYK2 portfolio.