Alumis Announces New Phase 3 Data Demonstrating Envudeucitinib Rapidly and Durably Improved Psoriasis Burden Across Scalp, Itch, and Quality of Life Measures
Globe Newswire•09/10/2026•04:00 ET
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Key Highlights
- ➤54% PASI 100 response rate at Week 48, highest publicly reported among oral psoriasis therapies
- ➤Over 80% of ONWARD3 patients maintained clear or almost clear scalp skin at Week 48
- ➤Nearly 80% sustained clinically meaningful itch reduction through Week 48
- ➤More than 70% maintained minimal-to-no quality-of-life impact at Week 48
- ➤Alumis remains on track to submit an NDA in fourth-quarter 2026
Expert Statements
Mark Lebwohl, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai
“For people living with psoriasis, achieving early and sustained relief in difficult-to-treat areas like the scalp and reduction of burdensome symptoms like itch are outcomes that can meaningfully improve quality-of-life”
Mark Lebwohl, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai
“The consistency of these findings across the ONWARD3 program—alongside high-threshold skin clearance and a favorable tolerability profile—is highly encouraging and underscores the clinical relevance of targeted TYK2 inhibition designed for maximal 24-hour target coverage.”
Martin Babler, Chief Executive Officer of Alumis
“The dataset presented at Fall Clinical further demonstrates envudeucitinib’s highly competitive clinical profile, reinforcing the strength of our precision engineering approach and its potential to become a leading therapy in the oral psoriasis market”
Martin Babler, Chief Executive Officer of Alumis
“With our fourth-quarter 2026 NDA submission firmly on track, our organization is focused on regulatory execution and building the foundation designed to bring this next-generation therapy to patients.”
– Results build on ONWARD3 highest complete skin clearance (54% PASI 100) at Week 48, reinforcing envudeucitinib’s potential to become a leading oral therapy for moderate-to-severe plaque psoriasis
– Patients switching from placebo or apremilast achieved rapid responses, comparable to those on continuous treatment at Week 48
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