SAN FRANCISCO, Sept. 1, 2026

Alumis Inc. announced topline results from its Phase 2b LUMUS trial of envudeucitinib in moderate-to-severe systemic lupus erythematosus (SLE), providing the company with new direction for the clinical development of its oral TYK2 inhibitor. While the study did not meet its primary and secondary endpoints in the overall trial population, Alumis identified a prespecified IFNGS-high patient subgroup in which envudeucitinib showed robust clinical responses. The company said these findings support further regulatory discussions regarding a potential Phase 3 development program in SLE. The LUMUS study was designed to evaluate envudeucitinib in adults with moderately-to-severely active, autoantibody-positive SLE, with patients receiving multiple doses of the investigational therapy or placebo. The company’s latest update therefore centers on refining the development strategy around patient populations most closely aligned with the drug’s intended Type I interferon pathway mechanism.

LUMUS Results Shape SLE Development Strategy

The LUMUS findings provide Alumis with a more targeted framework for advancing envudeucitinib in systemic lupus erythematosus. The company reported robust responses in the prespecified IFNGS-high subgroup, including activity on the trial’s primary endpoint, the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA). Additional improvements were reported across selected disease activity measures, including CLASI-50, SRI-4 and LLDAS. According to Alumis, IFNGS-high patients represent a substantial portion of people with moderate-to-severe SLE and may be more responsive to therapies directed at the interferon pathway. The company said that this population was unexpectedly under-represented in the overall LUMUS study, contributing to the weaker aggregate efficacy outcome. Rather than treating the overall Phase 2b result as sufficient to establish efficacy across an unselected SLE population, Alumis plans to use the subgroup findings and biomarker data to guide discussions with regulators on the design and positioning of a potential Phase 3 SLE program

Envudeucitinib Shows Target Engagement

The company also reported pharmacodynamic findings supporting dose-dependent inhibition of the interferon pathway. Envudeucitinib produced increasingly strong target suppression with increasing exposure, with maximal suppression observed at the highest evaluated dose of 40 mg twice daily. These findings are important for the program because they provide biological evidence that the investigational therapy is engaging its intended TYK2-mediated pathway in patients. Alumis is developing envudeucitinib as a highly selective oral allosteric TYK2 inhibitor designed to provide sustained TYK2 inhibition over 24 hours. The company believes this mechanism could support development across several interferon-driven immune-mediated diseases, extending beyond SLE into areas such as cutaneous lupus erythematosus and Sjögren’s disease. Envudeucitinib was generally well tolerated in the LUMUS study, with Alumis reporting no new safety signals from the Phase 2b program.

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Alumis Maintains Broader Late-Stage Development Plans

Beyond the SLE program, Alumis continues to advance envudeucitinib toward regulatory submission in plaque psoriasis, maintaining the broader development strategy for its TYK2 portfolio. The company remains on track to submit an NDA for moderate-to-severe plaque psoriasis in the fourth quarter of 2026, following positive results from its Phase 3 ONWARD program. The SLE findings will now become an important part of the company’s regulatory strategy as Alumis evaluates how best to move the program into later-stage development. The company is also developing A-005 for neuroinflammatory and neurodegenerative diseases, including Parkinson’s disease, while using its precision-focused approach to identify additional immune-mediated disease opportunities. For envudeucitinib, the immediate priority is the planned regulatory engagement on Phase 3 development in SLE, while the psoriasis NDA remains the nearer-term regulatory milestone. The company’s latest update therefore positions envudeucitinib as a potentially broader oral TYK2 development platform, with future progress dependent on regulatory feedback and confirmation of the biomarker-defined clinical strategy.

Source : Alumis,,press relese