Alumis' lupus trial misses endpoints, but company eyes phase 3 in IFNGS‑high subgroup

Alumis reported that its phase 2b study of the TYK2 inhibitor envudeucitinib failed to meet both the primary and secondary efficacy endpoints in patients with moderate to severe systemic lupus erythematosus.

The trial enrolled 408 autoantibody‑positive adults who received one of three oral doses of envudeucitinib or placebo for 48 weeks. The drug showed no statistically significant improvement over placebo on the overall disease‑activity measure, leading to the missed primary goal and secondary readouts.

Following the announcement, Alumis shares dropped about 54% in pre‑market trading, reflecting investor disappointment. Despite the overall negative outcome, the company highlighted a prespecified subgroup of patients with a high interferon‑gene signature that appeared to benefit from the therapy.

Alumis’ CEO Martin Babler said the subgroup data supports the drug’s mechanism of action and justified advancing envudeucitinib into a phase 3 trial focused on that patient population, which the company believes represents a sizable market opportunity.