Alumis Trial Results Propel 2026 FDA Bid
Alumis trial results showed short-term tolerability in two Phase 3 studies, prompting an FDA NDA in H2 2026 and likely to reprice shares.
KEY TAKEAWAYS
- Two Phase 3 trials met co-primary endpoints; 74% achieved PASI 75 at Week 16.
- Statistically superior to placebo and apremilast with p<0.0001 and early separation by Week 4.
- Safety through Week 24 was well tolerated with mostly mild-to-moderate adverse events and no new signals.
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Alumis released trial results on Jan. 6 showing that two Phase 3 studies of envudeucitinib met co-primary endpoints with high Psoriasis Area and Severity Index (PASI) response rates and an acceptable safety profile. The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2026.
Phase 3 Efficacy and Trial Design
The ONWARD1 and ONWARD2 trials were parallel, global, randomized, double-blind Phase 3 studies that together enrolled more than 1,700 patients. Participants were randomized in a 2:1:1 ratio to receive envudeucitinib 40 mg twice daily, placebo, or apremilast. Envudeucitinib is a next-generation oral selective TYK2 inhibitor targeting the IL-23 and IL-17 pathways implicated in plaque psoriasis.
The co-primary endpoints at Week 16 were PASI 75 (at least 75% improvement in psoriasis severity) and static Physician’s Global Assessment (sPGA) 0/1 (clear or almost clear skin). Across both trials, 74% of patients achieved PASI 75 and 59% reached sPGA 0/1 at Week 16. By Week 24, about 65% attained PASI 90 and more than 40% achieved complete clearance (PASI 100). Separation from placebo was evident by Week 4. The results were statistically superior to both placebo and apremilast across all endpoints (p<0.0001).
Safety, Regulatory Plans, and Next Steps
Envudeucitinib was well tolerated through Week 24, with mostly mild to moderate adverse events including headache, nasopharyngitis, upper respiratory infection, and acne. No new safety signals emerged. A long-term extension study, ONWARD3, is ongoing to assess durability and longer-term safety.
Alumis intends to file an NDA with the FDA in the second half of 2026 and will present detailed trial data at an upcoming medical meeting. The company is also conducting a Phase 2b LUMUS study of envudeucitinib in systemic lupus erythematosus, with pivotal results expected later this year.
