– Both Phase 3 trials met all primary and secondary endpoints with high statistical significance in patients with moderate-to-severe plaque psoriasis –
– Approximately 65% of patients achieved PASI 90 and more than 40% achieved PASI 100 at Week 24, on average –
– Envudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 program –
– Alumis plans to submit a New Drug Application to the FDA in the second half of 2026 –
– Conference call and webcast scheduled for 8:00 a.m. ET today –
SOUTH SAN FRANCISCO, Calif., Jan. 06, 2026 (GLOBE NEWSWIRE) — Alumis Inc. (Nasdaq: ALMS), a late-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced positive topline results from its Phase 3 ONWARD1 and ONWARD2 clinical trials of envudeucitinib, a next-generation highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis.
Envudeucitinib met all primary and secondary endpoints with high statistical significance in ONWARD1 and ONWARD2. In each of these trials, envudeucitinib achieved superior skin clearance compared with placebo (p < 0.0001) on the co‑primary endpoints of Psoriasis Area and Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0/1 at Week 16. On average across both ONWARD1 and ONWARD2, 74% of patients achieved PASI 75 and 59% of patients achieved sPGA 0/1, with responses deepening over time. In addition, the placebo-adjusted response rates for the co-primary endpoints were consistent between the two trials.
At Week 24, on the higher hurdle skin clearance measures, approximately 65% of patients achieved PASI 90, and more than 40% achieved PASI 100, on average across both trials. Rapid responses were observed, with clear separation from placebo on PASI 90 as early as Week 4. In addition, consistent and clinically meaningful improvements across patient-reported outcomes relating to itch and quality of life were observed. Envudeucitinib also achieved superior skin clearance compared with apremilast in each trial (p<0.0001) on all PASI endpoints at Week 24.
“We believe envudeucitinib demonstrates the full promise of TYK2 inhibition,” said Dr. Jörn Drappa, Chief Medical Officer of Alumis. “By maximally inhibiting TYK2, envudeucitinib blocks both IL‑23 and IL‑17 to deliver comprehensive disease control. In Phase 3, this translated into rapid onset of action, high rates of skin clearance, and meaningful symptom improvements that rank among the strongest reported for an oral therapy. We are deeply grateful to the patients, families, and investigators whose commitment made this milestone possible.”