Envudeucitinib Phase 3 ONWARD Trial Results Unveiled

Alumis Inc. has announced positive topline results from its Phase 3 ONWARD1 and ONWARD2 trials evaluating envudeucitinib, a next-generation selective TYK2 inhibitor, in patients with moderate-to-severe plaque psoriasis. The data signal a potentially role for envudeucitinib among targeted immune therapies, particularly for patients seeking alternatives to injectable biologics.

Envudeucitinib met all primary and secondary endpoints with high statistical significance in both trials. By week 16, 74 percent of patients achieved at least a 75 percent improvement in Psoriasis Area and Severity Index (PASI 75), while 59 percent reached a static Physician’s Global Assessment (sPGA) score of 0 or 1. Responses deepened through Week 24, with approximately 65 percent of patients achieving PASI 90 and over 40 percent reaching complete skin clearance (PASI 100).

Notably, envudeucitinib demonstrated superiority over placebo as early as Week 4 on higher bar endpoints like PASI 90, suggesting rapid onset of action. It also outperformed apremilast, an established oral therapy, across all PASI measures at Week 24 (p < 0.0001).

The trials also showed consistent, clinically meaningful improvements in itch reduction and health-related quality of life, reinforcing envudeucitinib’s potential impact beyond skin clearance.

The safety profile through Week 24 was consistent with prior Phase 2 data. Treatment-emergent adverse events (TEAEs) were mostly mild to moderate and transient. Common TEAEs included headache, nasopharyngitis, upper respiratory tract infections, and acne. No new safety signals were identified.