ONWARD: A Pivotal Phase 3 Program

All primary and secondary endpoints were met with high statistical significance in the Phase 3 trials—ONWARD1 and ONWARD2— of envudeucitinib in patients with moderate-to-severe plaque psoriasis. 

In these trials, envudeucitinib demonstrated early and robust improvements in skin clearance, quality of life, and psoriasis symptoms, alongside a favorable safety profile. Key findings included:

Robust and Deepening Skin Clearance

• PASI  90 responses emerged as early as Week 4 and achieved by 59.9% and 53.1% of envudeucitinib patients at Week 16 (and by 4.8% and 4.3% of placebo patients), increasing to 68.0% and 62.1% at Week 24. 
• PASI 100 rates followed a similar trajectory, with 29.4% and 27.7% of envudeucitinib patients achieving complete skin clearance at Week 16 (as compared to 0.9% and 0.9% of placebo patients), rising to 41.0% and 39.5% at Week 24. 
  
  

Meaningful Improvements in Scalp Psoriasis

• At Week 24, approximately three out of four patients² achieved ss-PGA³ 0/1 (clear or almost clear scalp), with over 30% responding as early as Week 4.
   

Early and Broad Benefits Beyond Skin Clearance

• By Week 12, approximately 50% of patients⁴ achieved DLQI⁵ 0/1, demonstrating minimal to no impact of psoriasis on quality of life. 
• By Week 16, patients achieved an average >4 point improvement from baseline on the 0-10 Worst Pruritus NRS , with clinically meaningful itch relief as early as Week 2—one of the most burdensome symptoms of psoriasis.
   

Favorable Safety Profile

• Envudeucitinib was generally well tolerated, with a safety profile consistent with the Phase 2 program, including its long-term extension study.

Next Steps in Development

ONWARD3, a long-term extension study for patients who completed Week 24 of ONWARD1 or ONWARD2, is currently ongoing to evaluate the durability of response, maintenance of efficacy, and long-term safety of envudeucitinib. 

Alumis plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of 2026. 

Envudeucitinib is also being advanced in a Phase 2b clinical trial in systemic lupus erythematosus (SLE), with the potential for future indications.

 

¹Psoriasis Area and Severity Index
²Based on patients with baseline ss-PGA ≥3 
³Scalp Specific Physician’s Global Assessment
⁴Based on patients with baseline DLQI ≥2
⁵Dermatology Life Quality Index
⁶Worst Pruritus Numeric Rating Scale
*Envudeucitinib is an investigational drug, not reviewed or approved by any regulatory agency