Envudeucitinib for Plaque Psoriasis

Envudeucitinib* is a next-generation, highly selective, oral tyrosine kinase 2 (TYK2) inhibitor precision-engineered for maximal 24-hour inhibition 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 indicates that its selective targeting delivered sustained, maximal 24-hour inhibition in patients with psoriasis while minimizing off-target binding and effects. 

How Envudeucitinib Works 

 

ONWARD: A Pivotal Phase 3 Program

The Phase 3 ONWARD1 and ONWARD2 trials met all primary and secondary endpoints for envudeucitinib in moderate-to-severe plaque psoriasis. Topline results from the ongoing ONWARD3 long-term extension study reinforces these findings, demonstrating durable, high rates of skin clearance after 48 weeks and a favorable, consistent safety profile with no new safety signals observed. Alumis plans to present additional results from the ONWARD program at upcoming medical meetings.

Next Steps in Development

Alumis plans to submit a New Drug Application (NDA) to the FDA seeking approval for envudeucitinib for the treatment of moderate-to-severe plaque psoriasis in the fourth quarter of 2026.

 

*Envudeucitinib is an investigational drug, not reviewed or approved by any regulatory agency