Alumis Inc. announced positive topline results from Phase 3 ONWARD1 and ONWARD2 trials of envudeucitinib in patients with plaque psoriasis.
Approximately 65% of patients achieved PASI 90 and more than 40% achieved PASI 100 at Week 24 on average.
Envudeucitinib demonstrated favorable safety and tolerability consistent with 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.
Positive Topline Results
Envudeucitinib met all primary and secondary endpoints in Phase 3 trials with high statistical significance.
Skin Clearance Rates
65% of patients achieved PASI 90 and 40% achieved PASI 100 at Week 24 on average.
Safety and Tolerability Profile
Favorable safety profile consistent with Phase 2 program.
FDA Submission
Alumis plans to submit a New Drug Application to the FDA in the second half of 2026.
Future Presentations
Additional trial results and NDA submission planned for systemic lupus erythematosus.
- Envudeucitinib achieved superior skin clearance compared to placebo with high statistical significance.
- Rapid responses observed as early as Week 4 with deepening responses over time.
- Patients reported meaningful improvements in itch and quality of life.
- Envudeucitinib showed superiority to apremilast in skin clearance at Week 24.
The positive Phase 3 trial results for envudeucitinib mark a significant advancement in psoriasis treatment, suggesting a potential new oral therapy option with high efficacy and safety.