Clinical TrialAug 10, 2026, 04:13 PM
Alumis Envudeucitinib Long-Term Data Shows 54% PASI 100 in Psoriasis
AI Summary
Alumis Inc. announced positive topline results from the ONWARD3 long-term extension study for envudeucitinib, an investigational oral TYK2 inhibitor for plaque psoriasis. The data showed 54% of patients achieved complete skin clearance (PASI 100) after 48 weeks, positioning it as a potential new standard among oral therapies. The treatment maintained a favorable long-term safety profile, consistent with previous findings. The company is on track to submit a New Drug Application to the FDA in the fourth quarter of 2026.
Key Highlights
- 54% of patients achieved complete skin clearance (PASI 100) after 48 weeks of continuous envudeucitinib treatment.
- 75% of patients achieved PASI 90 after 48 weeks of continuous envudeucitinib treatment.
- Approximately 90% of patients who achieved PASI 90 sustained it, and 80% sustained PASI 100.
- Integrated analysis across ONWARD program showed 66% PASI 90 and 47% PASI 100 after 48 weeks.
- Favorable long-term safety and tolerability profile remained consistent with previously reported data.
- Alumis plans to submit a New Drug Application (NDA) to the FDA in Q4 2026.
- Topline data from LUMUS Phase 2b trial in systemic lupus erythematosus expected in Q3 2026.
Price Impact
More from ALMS