US biopharmaceutical company Alumis Inc. (NASDAQ: ALMS) on Friday released new Phase 3 data from its ONWARD1, ONWARD2 and ONWARD3 studies of envudeucitinib in moderate-to-severe plaque psoriasis.
Envudeucitinib delivered high-threshold skin clearance across the programme, including a 54% Psoriasis Area and Severity Index (PASI) 100 response at Week 48, which Alumis said is the highest publicly reported rate among existing and investigational oral psoriasis therapies. Alumis said the data also showed early and durable improvements in scalp disease severity, itch reduction and quality-of-life measures.
In ONWARD3, more than 80% of patients maintained clear or almost clear scalp skin at Week 48. Across ONWARD1/2, around one-third achieved clinically meaningful itch reduction by Week 2, rising to about 40% with complete itch resolution by Week 16; nearly 80% sustained meaningful itch reduction through to Week 48 in ONWARD3.
Approximately 50% of ONWARD1/2 patients reached a Dermatology Life Quality Index (DLQI) score of 0 or 1 by Week 12 and more than 70% maintained this level at Week 48 in ONWARD3.
Envudeucitinib was generally well tolerated, with no new safety signals observed in long-term exposure.
Alumis plans to submit an NDA for envudeucitinib in moderate-to-severe plaque psoriasis in the fourth quarter of 2026.
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