Alumis Inc

Alumis Inc. reported that its 408-patient Phase 2b LUMUS trial of envudeucitinib in moderate-to-severe systemic lupus erythematosus did not meet primary or secondary endpoints in the overall population, yet the company plans end-of-Phase 2 meetings with the FDA and European Medicines Agency based on a prespecified subgroup with a high interferon gene signature. In the overall population, BICLA response rates were 40.0%, 42.2%, and 41.0% for the 20-milligram once-daily, 20-milligram twice-daily, and 40-milligram twice-daily regimens, respectively, versus 35.7% for placebo, with p-values of 0.5018, 0.3455, and 0.3740. In the IFNGS-high subgroup, which comprised approximately 59% to 63% of each treatment group, numerical BICLA response rates were 40.7%, 49.5%, and 52.6% for the three doses versus 28.6% for placebo, with covariate-adjusted differences of 11.6, 21.3, and 24.0 percentage points. The company noted that the IFNGS-high share was below the approximately 70% generally expected, and that pharmacodynamic data showed dose-dependent target engagement with maximal suppression at 40 milligrams twice daily. Alumis plans to discuss Phase 3 dose, design, size, and biomarker-based enrollment criteria with regulators, though the subgroup evidence lacks confidence intervals and p-values, and the dose pattern was not uniform across endpoints.