Alumis announced positive 52-week data from the open-label extension of its Phase 2 STRIDE trial for ESK-001, an oral TYK2 inhibitor, in moderate-to-severe plaque psoriasis. Results presented at the 2025 American Academy of Dermatology meeting showed sustained and increasing clinical responses in patients receiving 40mg twice daily. The therapy continued to be well-tolerated with no new safety concerns.
This data strengthens the case for ESK-001 as a potential oral alternative to biologics for psoriasis. Demonstrating sustained efficacy and safety over a year is crucial for establishing the drug’s long-term value proposition, especially in a chronic condition like psoriasis. This data could influence treatment paradigms by offering a convenient and effective option for patients who prefer oral medication or haven’t responded well to other treatments. The sustained improvements in itch and quality of life measures further underscore the drug’s potential impact on patients’ daily lives.
At week 52, PASI 90, PASI 100, and sPGA 0 scores were 61.3%, 38.8%, and 38.8% respectively, compared to 52.4%, 26.8%, and 32.9% at week 12. Control of itch (NRS≤4) was reported in 81.3% of patients, and 61.3% achieved a quality-of-life score of DLQI0/1. The Phase 3 ONWARD program, consisting of two trials (ONWARD1 and ONWARD2), is currently enrolling patients, with topline data anticipated in Q1 2026. A once-daily modified release formulation is also in development.
The positive long-term data and ongoing Phase 3 trials position ESK-001 as a promising candidate in the TYK2 inhibitor landscape for psoriasis. Positive Phase 3 results could lead to regulatory submission and potential market entry, offering a new oral therapeutic option for patients. The development of a once-daily formulation could further enhance patient convenience and adherence, potentially differentiating ESK-001 in a competitive market.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
