Phase 3 envudeucitinib data in moderate-to-severe plaque psoriasis; PASI 100 response rate 54% at Week 48
- ONWARD3 included 1,509 patients; data from 773 patients who received up to 48 weeks of continuous treatment showed over 80% maintained clear or almost clear scalp skin at Week 48, and nearly 80% sustained clinically meaningful itch reduction through Week 48.
- In ONWARD1/2, approximately one-third achieved clinically meaningful itch reduction by Week 2; about 40% had complete itch resolution and approximately 60% reported minimal or no itch at Week 16. More than 1,700 patients were enrolled and randomized across ONWARD1/2.
- Patients switching from placebo or apremilast achieved rapid improvements comparable to continuous treatment at Week 48. No new long-term safety signals were observed.
- NDA submission in moderate-to-severe plaque psoriasis remains on track for Q4 2026.
TTN Note: The Week 48 efficacy denominator is 773 continuous-treatment extension patients, versus 892 originally randomized to envudeucitinib—119 fewer patients. Non-responder imputation within that extension cohort does not establish durability across the full original randomized population; the release does not explain the exclusions.
- The “highest publicly reported” PASI 100 claim is a cross-trial comparison, not demonstrated superiority over other TYK2 inhibitors. Apremilast was the active comparator, and crossover convergence at Week 48 measures response after switching rather than continued comparative efficacy.
- “Durable” here means sustained response on treatment, not persistence after stopping. ONWARD3 includes randomized withdrawal in the first 200 qualifying PASI 75 responders, but this release provides no withdrawal results or time-to-relapse data.
- Maximal 24-hour target coverage requires 40 mg twice daily in these trials; it is not a once-daily convenience claim. The commercial balance between clearance and dosing burden also needs quantified long-term adverse events and discontinuations, which “no new safety signals” does not supply.