SOUTH SAN FRANCISCO, Calif. — October 9, 2026
Alumis Inc. (Nasdaq: ALMS), a late-stage biopharmaceutical company developing targeted therapies for immune-mediated diseases, announced new Phase 3 findings for envudeucitinib from its ONWARD1, ONWARD2 and ONWARD3 clinical program. Presented at the 26th Annual Fall Clinical Dermatology Conference, the results showed improvements in scalp psoriasis, itch and quality of life among patients with moderate-to-severe plaque psoriasis. The findings build on previously reported Week 48 data showing a 54% PASI 100 response rate, representing complete skin clearance, in ONWARD3. Alumis is evaluating envudeucitinib as a potential oral treatment option for patients seeking sustained disease control.
Scalp Clearance and Itch Relief Sustained Through Week 48
In ONWARD3, more than 80% of patients maintained clear or almost-clear scalp skin at Week 48, measured using the scalp-specific Physician Global Assessment. Across ONWARD1 and ONWARD2, approximately one-third of patients achieved clinically meaningful itch reduction by Week 2, including those with moderate-to-severe scalp involvement. By Week 16, approximately 40% reported complete itch resolution, while around 60% experienced minimal or no itch. In ONWARD3, nearly 80% sustained clinically meaningful itch reduction through Week 48. These findings highlight improvements in symptoms and difficult-to-treat areas that can substantially affect daily life for people living with psoriasis.
Quality-of-Life Improvements and Long-Term Safety
Approximately 50% of patients in ONWARD1 and ONWARD2 achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1 by Week 12, indicating minimal or no impact of psoriasis on quality of life. In ONWARD3, more than 70% maintained these scores at Week 48. Patients who switched from placebo or apremilast to envudeucitinib also experienced rapid improvements across primary and key secondary endpoints, with outcomes comparable to those receiving continuous treatment by Week 48. Alumis reported that envudeucitinib was generally well tolerated across the ONWARD program and that no new safety signals emerged with longer-term exposure in ONWARD3.
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Alumis Targets Fourth-Quarter 2026 NDA Submission
Envudeucitinib is an investigational, selective oral tyrosine kinase 2 (TYK2) inhibitor designed to provide sustained target inhibition over 24 hours. The Phase 3 ONWARD1 and ONWARD2 trials enrolled more than 1,700 patients and evaluated the treatment against placebo and apremilast, while ONWARD3 assesses longer-term efficacy, durability and safety. Alumis remains on track to submit a New Drug Application (NDA) to the U.S. FDA in the fourth quarter of 2026 for moderate-to-severe plaque psoriasis. The therapy has not yet received FDA approval for this indication, and its clinical benefits and risks remain subject to regulatory review.
Source::Alumis, press release
