Alumis Inc. announced positive 24-week Phase 3 trial results for its oral TYK2 inhibitor envudeucitinib in moderate-to-severe plaque psoriasis, demonstrating robust skin clearance and symptom improvement, with plans to submit an NDA in the second half of 2026.
Key takeaways
Envudeucitinib achieved PASI 90 responses of 68.0% and 62.1% at Week 24 in the ONWARD1 and ONWARD2 trials, respectively.
Envudeucitinib achieved PASI 100 responses of 41.0% and 39.5% at Week 24 in the ONWARD1 and ONWARD2 trials, respectively.
Approximately three out of four envudeucitinib patients achieved clear or almost clear scalp psoriasis at Week 24, with over 30% responding as early as Week 4.
Alumis plans to submit a New Drug Application to the U.S. Food and Drug Administration for envudeucitinib in the second half of 2026.
Envudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 program, with no new safety signals observed.