ESK-001 - (ONWARD3)

Aug. 10, 2026: Alumis (NASDAQ: ALMS) reported topline results from the ongoing Phase 3 ONWARD3 long-term extension study of envudeucitinib in moderate-to-severe plaque psoriasis. In a non-responder imputation analysis of 773 patients who received up to 48 weeks of continuous treatment, 75% achieved PASI 90 and 54% achieved PASI 100. Among patients entering ONWARD3 with PASI 90 or PASI 100 responses, about 90% and 80%, respectively, maintained those responses through the reported extension period.

A separate integrated NRI analysis across ONWARD1/2/3 in 890 patients originally randomized to envudeucitinib showed 66% achieved PASI 90 and 47% achieved PASI 100 at 48 weeks. The company said ONWARD3 safety remained consistent with ONWARD1/2, with no new safety signals.

The ONWARD program includes ONWARD1 and ONWARD2, two 24-week Phase 3 trials versus placebo and apremilast, and ONWARD3, an ongoing long-term extension designed to provide up to 96 weeks of data.

Alumis said it remains on track to submit an NDA to the FDA in 4Q 2026 for envudeucitinib in moderate-to-severe plaque psoriasis. Additional ONWARD data are planned for upcoming medical meetings. The company also expects topline data from the LUMUS Phase 2b trial in systemic lupus erythematosus in Q3 2026.