Envudeucitinib for Plaque Psoriasis

Envudeucitinib is a next-generation highly selective oral tyrosine kinase 2 (TYK2) inhibitor designed to correct immune dysregulation across a range of diseases driven by proinflammatory mediators such as IL-23 and IL-17, including plaque psoriasis. Clinical data indicate its selective targeting delivered sustained, maximal 24-hour inhibition in patients with psoriasis while minimizing off-target binding and effects

ONWARD: A 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. Envudeucitinib delivered leading skin clearance among next-generation oral plaque psoriasis therapies, with approximately 65% patients achieving PASI 90 and more than 40% achieving PASI 100 at Week 24, on average across the two trials. Envudeucitinib also was generally well tolerated, with a safety profile consistent with our Phase 2 program.  

Additional key findings include:

  • Superior skin clearance versus placebo on the co-primary endpoints of PASI 75 and sPGA* 0/1 at Week 16 
  • Consistent and clinically meaningful improvements across patient reported outcomes related to itch and quality of life
  • Rapid onset of effect, with clear separation from placebo on PASI 90 as early as Week 4

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 present additional ONWARD1 and ONWARD2 results at an upcoming medical meeting and intends 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 of future indications including psoriatic arthritis, inflammatory bowel disease, and other chronic inflammatory conditions.

 

* Psoriasis Area and Severity Index (PASI)
* static Physician’s Global Assessment (sPGA)