Alumis has announced positive top line data from its Phase III ONWARD1 and ONWARD2 clinical trials evaluating envudeucitinib, a selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis.
The results showed that envudeucitinib achieved all primary and secondary endpoints with high statistical significance in both studies.
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At week 16, the therapy demonstrated greater skin clearance than placebo on the co-primary endpoints of Psoriasis Area and Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0/1, in both ONWARD1 and ONWARD2.
On average, 74% of patients attained PASI 75, while 59% reached sPGA 0/1 across the two trials. These responses increased over time, with placebo-adjusted rates remaining consistent between the studies.
At week 24, nearly 65% of patients attained PASI 90, and over 40% achieved PASI 100 on average. Rapid responses were noted, with clear differentiation from placebo on PASI 90 as early as week four.
Patients also reported clinically meaningful improvements in quality of life and itch. Envudeucitinib is also said to have outperformed apremilast on all PASI endpoints at week 24 in each trial.
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By GlobalDataAlumis chief medical officer Dr Jörn Drappa said: “We believe envudeucitinib demonstrates the full promise of TYK2 inhibition. By maximally inhibiting TYK2, envudeucitinib blocks both IL 23 and IL 17 to deliver comprehensive disease control.
“In Phase III, this translated into rapid onset of action, high rates of skin clearance, and meaningful symptom improvements that rank among the strongest reported for an oral therapy. We are deeply grateful to the patients, families, and investigators whose commitment made this milestone possible.”
The safety profile through week 24 was consistent with Alumis’ previous Phase II studies, including long-term extension data.
Treatment-emergent adverse events were mostly mild to moderate and transient; the most common were nasopharyngitis, headaches, acne, and upper respiratory tract infections. No new safety signals emerged.
Alumis expects to present further ONWARD1 and ONWARD2 results at an upcoming medical meeting and plans a new drug application submission to the US Food and Drug Administration (FDA) in the second half of this year.
In May 2025, Alumis concluded enrolment in its pivotal Phase III ONWARD programme, which aimed to assess the safety and efficacy of the oral TYK2 inhibitor, ESK-001, for treating adults with moderate-to-severe plaque psoriasis.
