Alumis Inc. (Nasdaq: ALMS) said its Phase 2b LUMUS trial evaluating envudeucitinib in patients with moderate-to-severe systemic lupus erythematosus (SLE) did not meet its primary or secondary endpoints in the overall study population.
The trial enrolled 408 patients who received one of three doses of envudeucitinib or placebo over 48 weeks.
The primary endpoint assessed overall disease activity at Week 48 using the British Isles Lupus Assessment Group-based Composite Lupus Assessment, or BICLA.
Prespecified subgroup shows responses
Alumis reported that a prespecified subgroup of patients with a high interferon gene signature, or IFNGS-high, showed responses on the primary endpoint and several key secondary measures.
These included CLASI-50, SRI-4 and Lupus Low Disease Activity State.
According to Alumis, IFNGS-high patients were unexpectedly under-represented in the overall trial population. The company cited this as a factor that reduced response rates across the study.
The subgroup findings do not change the fact that the trial failed to meet its primary and secondary endpoints in the overall population and will require further evaluation.
“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.”
Alumis plans regulatory discussions on Phase 3 development
Pharmacodynamic results from LUMUS showed dose-dependent target engagement in the interferon pathway, with the greatest suppression observed at the 40mg twice-daily dose.
Alumis also reported that no new safety signals were identified during the study.
The company plans to discuss potential Phase 3 development of envudeucitinib in SLE with regulators. Any progression into Phase 3 remains subject to those discussions and future development decisions.
Psoriasis NDA remains planned for fourth quarter
Separately, Alumis said it remains on schedule to submit a New Drug Application for envudeucitinib in moderate-to-severe plaque psoriasis during the fourth quarter of 2026.
The planned submission follows previously reported positive Phase 3 results from the company’s ONWARD programme.
Envudeucitinib remains subject to regulatory review and has not been approved for the indications described in the supplied information.
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