Alumis has concluded enrolment in its pivotal Phase III ONWARD programme, aimed to assess the safety and efficacy of the oral tyrosine kinase 2 (TYK2) inhibitor, ESK-001, for treating adults with moderate-to-severe plaque psoriasis.
The programme comprises two global parallel Phase III trials, ONWARD1 and ONWARD2, and an optional long-term extension trial, ONWARD3.
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More than 1,700 subjects have been enrolled across the placebo-controlled, randomised, double-blind, 24-week, multi-centre ONWARD1 and ONWARD2 trials. Subjects were randomised into a 2:1:1 ratio and given either 40mg of the therapy twice a day, a placebo, or apremilast.
The trials’ co-primary efficacy endpoints are the proportion of subjects achieving an improvement of 75% in the Psoriasis Area and Severity Index (PASI 75) and a score of 0/1 on the static Physician’s Global Assessment (sPGA) at week 16.
Following the completion of week 24, subjects may join ONWARD3 to assess the treatment’s durability and long-term safety.
Alumis CEO and president Martin Babler said: “We are excited to announce the completion of patient enrolment in our pivotal Phase III ONWARD clinical programme evaluating ESK-001 for moderate-to-severe plaque psoriasis.
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By GlobalData“With over 1,700 patients enrolled across the two trials, this milestone reflects the dedication of our patients, investigators, and the Alumis team, whose efforts have made it possible. We remain on track to report topline results in early Q1 2026, bringing us closer to delivering transformative treatment solutions for patients in need.”
Support for this Phase III programme comes from positive data from the Phase II STRIDE trial and the ongoing open-label extension.
Alumis is also developing a once-a-day, modified-release oral formulation to replace the current immediate-release formulation.
In addition to plaque psoriasis, ESK-001 is under investigation in the Phase IIb LUMUS trial for systemic lupus erythematosus.
Alumis continues to explore the therapy in other immune-mediated conditions through its precision data analytics platform.
Last December, the company reported positive outcomes from a Phase I trial of the selective TYK2 inhibitor, A-005, in healthy subjects.
