Late-Breaking ESK-001 Data from the OLE STRIDE Trial Presented at AAD 2025

At the 2025 American Academy of Dermatology Association (AAD) Annual Meeting in Orlando, Florida, Alumis Inc. shared promising late-breaker results from the open-label extension (OLE) phase 2 STRIDE clinical trial for ESK-001.¹ Positive clinical responses and improvements in quality of life were observed after 52 weeks in patients with moderate-to-severe plaque psoriasis.

“We’re excited to see that ESK-001 continues to demonstrate a favorable clinical profile for the potential treatment of moderate-to-severe plaque psoriasis, with the ability to improve clinical outcomes as well as patients’ reported symptoms and quality of life," Jörn Drappa, MD, Chief Medical Officer, said in a statement. "We believe in the potential of ESK-001 to fill a critical gap in psoriasis patient care as an oral therapy that is well tolerated and may provide biologic-like clinical responses."¹

Patients who received 40 mg of ESK-001 twice a day (n = 80) saw sustained or increased improvements after 52 weeks, compared to 12 weeks. Over 60% of patients reached a Psoriasis Area and Severity Index (PASI) of 90 at week 52, compared to 52.4% at week 12. Almost 40% reached PASI 100 at week 52 versus 26.8% at week 12. Additionally, the Static Physician's Global Assessment (sPGA) for Psoriasis score of 0 was achieved in 38.8% of patients at week 52.

Similar positive results in safety and tolerability were also observed at 1 year. Over 80% of patients saw improvements in itch control with a score ≤4 on the Itch Numeric Rating Scale (NRS). Quality of life, according to a score of 0 or 1 on the Dermatology Life Quality Index (DLQI), was reached in 61.3% of participants. Furthermore, no new safety findings were recorded, remaining consistent with previous data, including 28-week results that were presented at the 2024 European Academy of Dermatology & Venereology (EADV).² The most frequently reported adverse effects were mild to moderate upper respiratory tract infections, nasopharyngitis, and headaches.

ESK-001 is a highly selective allosteric inhibitor of tyrosine kinase 2 (TYK2), a key target in treating various immune-mediated conditions. Its selective targeting delivers maximal inhibition while minimizing off-target binding and effects. Alumis is working to develop a modified version of the oral drug that will be administered once daily.

ESK-001 is also being evaluated in phase 3, multicenter, randomized, double-blind placebo-controlled ONWARD1 and ONWARD2 clinical trials, as well as the LUMUS Phase 2b trial for the treatment of systemic lupus erythematosus.

In a press release, Martin Babler, President and Chief Executive Officer, said, “These long-term data further support the highly differentiated profile of ESK-001 and reinforce its potential as a best-in-class TYK2 inhibitor for the oral treatment of moderate-to-severe plaque psoriasis. We continue to progress and enroll patients with moderate-to-severe psoriasis in the pivotal Phase 3 ONWARD studies and expect to report topline data in the first quarter of 2026.”¹

References

1. Late-Breaking ESK-001 Phase 2 OLE Data Presented at 2025 AAD Annual Meeting Demonstrate Robust Clinical Responses Over 52-Weeks in Psoriasis. News Release. Globe Newswire. March 8, 2025. Accessed March 11, 2025. https://www.globenewswire.com/news-release/2025/03/08/3039351/0/en/Late-Breaking-ESK-001-Phase-2-OLE-Data-Presented-at-2025-AAD-Annual-Meeting-Demonstrate-Robust-Clinical-Responses-Over-52-Weeks-in-Psoriasis.html

2. Late-breaking data at EADV of ESK-001, an oral TYK2 inhibitor for the treatment of psoriasis, demonstrate significant responses with sustained increases over 28 weeks in phase 2 OLE study. News Release. Alumis, Inc. September 27, 2024. Accessed March 11, 2025. https://investors.alumis.com/news-releases/news-release-details/late-breaking-data-eadv-esk-001-oral-tyk2-inhibitor-treatment