SOUTH SAN FRANCISCO, California, August 10, 2026

Alumis Inc. announced topline long-term results from the ongoing Phase 3 ONWARD3 study evaluating investigational oral envudeucitinib in patients with moderate-to-severe plaque psoriasis. The 48-week data showed that 54% of patients achieved complete skin clearance, measured by PASI 100, while 75% achieved PASI 90. Envudeucitinib is a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor engineered to provide sustained 24-hour target inhibition. The company said the results represent the highest reported PASI 100 response among existing and investigational oral psoriasis therapies, although cross-trial comparisons should be interpreted cautiously because different studies can have different patient populations and methodologies. A total of 1,509 patients entered ONWARD3 from the preceding ONWARD1 and ONWARD2 Phase 3 trials, representing a rollover rate of more than 85%. Alumis plans to submit a New Drug Application (NDA) to the FDA in the fourth quarter of 2026 for moderate-to-severe plaque psoriasis.

Envudeucitinib Delivers Durable Skin Clearance at 48 Weeks

Alumis reported that the strong efficacy observed in the earlier ONWARD trials continued through 48 weeks of treatment. Among 773 patients receiving continuous envudeucitinib treatment who were evaluated using non-responder imputation (NRI), 75% achieved PASI 90 and 54% achieved PASI 100 at Week 48. Importantly, patients who had already achieved strong responses entering ONWARD3 largely maintained those benefits during the extension period. Approximately 90% of patients who entered with PASI 90 and 80% of those entering with PASI 100 sustained their respective responses for the reported duration of the extension study. An integrated NRI analysis across the broader ONWARD program, including 890 patients originally randomized to envudeucitinib, showed that 66% achieved PASI 90 and 47% achieved PASI 100 after 48 weeks. These findings suggest that treatment response may not only emerge rapidly but also remain durable with continued therapy, an important consideration for patients with chronic plaque psoriasis who require long-term disease control.

Long-Term Safety Remains Consistent With Earlier Trials

The ONWARD3 safety profile remained consistent with previously reported findings from ONWARD1 and ONWARD2, with no new safety signals identified during longer-term treatment. Envudeucitinib is designed as a highly selective oral allosteric TYK2 inhibitor intended to selectively modulate immune signaling pathways involving IL-23, IL-17 and Type I interferon. Alumis has engineered the molecule to provide sustained TYK2 inhibition over 24 hours while minimizing off-target activity. The ONWARD Phase 3 program enrolled more than 1,700 patients across two global randomized studies, with participants receiving envudeucitinib, placebo or apremilast. Patients completing the initial 24-week trials could enter ONWARD3, which is designed to provide up to 96 weeks of long-term safety and efficacy data. The extension study also includes a randomized withdrawal component designed to evaluate the durability of treatment response. While the current results strengthen the clinical profile of envudeucitinib, longer follow-up and regulatory review will be important to establish its ultimate benefit-risk profile.

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Alumis Prepares FDA Submission for Envudeucitinib

Alumis plans to submit its NDA to the U.S. Food and Drug Administration in Q4 2026, seeking approval of envudeucitinib for moderate-to-severe plaque psoriasis. The company is also evaluating the therapy in other immune-mediated diseases, with topline data from the LUMUS Phase 2b trial in systemic lupus erythematosus (SLE) expected in the third quarter of 2026. Plaque psoriasis affects more than 8 million adults in the United States, and a substantial proportion of patients have moderate-to-severe disease that can significantly affect quality of life. Envudeucitinib is being positioned as a potential oral treatment option capable of delivering deep and durable skin clearance without the administration requirements associated with injectable biologic therapies. The 48-week ONWARD3 results, particularly the 54% PASI 100 response, provide an important clinical milestone for Alumis as the company moves toward regulatory submission and seeks to establish envudeucitinib as a potential next-generation oral therapy for plaque psoriasis.

Source:Alumis press release