Alumis Reports Positive Results for ESK-001 in Psoriasis Treatment
Alumis announced encouraging Phase 2 open-label extension (OLE) results for ESK-001, a TYK2 inhibitor targeting moderate-to-severe plaque psoriasis, demonstrating sustained clinical improvements over 52 weeks.
Key Findings from the Study
Alumis Inc. disclosed promising data from the open-label extension of its Phase 2 STRIDE trial for ESK-001, a selective oral tyrosine kinase 2 (TYK2) inhibitor, aimed at treating moderate-to-severe plaque psoriasis. During the 2025 AAD Annual Meeting, the company presented findings showing long-lasting clinical responses over a year of treatment, with notable improvements across various measures of disease severity and quality of life for patients. ESK-001 exhibited a favorable safety profile, with no new safety concerns identified. The company is advancing its Phase 3 ONWARD program, with topline results expected by the first quarter of 2026. Alumis officials express hope that ESK-001 could become a leading treatment option in the psoriasis market based on its promising profile and significant patient benefit potential.
Positive Aspects of ESK-001
- Phase 2 OLE results showcase sustained clinical responses for patients with moderate-to-severe plaque psoriasis over 52 weeks.
- ESK-001 was well tolerated without any new safety issues, reinforcing its safety credentials.
- The ongoing Phase 3 ONWARD program indicates continued evaluation, with topline results anticipated by Q1 2026.
- Potential recognition of ESK-001 as a best-in-class oral treatment enhances Alumis’ competitive position in the psoriasis market.
Challenges Ahead
- The ongoing Phase 3 ONWARD study means topline data will not be available until Q1 2026, extending the timeline for market entry.
- Uncertainties related to regulatory approval and commercialization could pose risks to the company’s future prospects.
- The disclosure of common treatment-emergent adverse events raises questions about safety and tolerability in advanced trials.
Frequently Asked Questions
What is ESK-001?
ESK-001 is a next-generation oral TYK2 inhibitor being developed for moderate-to-severe plaque psoriasis and systemic lupus.
How effective is ESK-001 for plaque psoriasis?
In the Phase 2 trials, ESK-001 showed sustained clinical responses, achieving significant improvements in PASI scores at week 52.
What are the safety findings for ESK-001?
ESK-001 was generally well tolerated, maintaining its safety profile over one year with no new safety concerns.
When will ESK-001 Phase 3 data be available?
Topline data from the Phase 3 ONWARD study of ESK-001 is expected in the first quarter of 2026.
What is Alumis’ focus in drug development?
Alumis is dedicated to developing precision oral therapies for immune-mediated diseases to enhance clinical outcomes and patient quality of life.
Disclaimer:
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Full Release Highlights
- ESK-001 is a highly selective, next-generation oral TYK2 inhibitor currently being evaluated for moderate-to-severe plaque psoriasis and systemic lupus.
- Phase 2 OLE data showed sustained or increasing clinical responses through week 52 on PASI 90, PASI 100, and sPGA 0 metrics.
- ESK-001 exhibited general tolerability over one year, with no new safety findings reported.
- These data support ESK-001’s potential as a differentiated, best-in-class treatment for moderate-to-severe plaque psoriasis.
- The Phase 3 ONWARD program is ongoing, with topline data expected in Q1 2026.
SOUTH SAN FRANCISCO, Calif., March 08, 2025 (GLOBE NEWSWIRE) — Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company focused on developing precision oral therapies for immune-mediated diseases, announced positive 52-week data from the open-label extension (OLE) of its Phase 2 STRIDE clinical trial evaluating ESK-001 in patients with moderate-to-severe plaque psoriasis. These results were highlighted during a late-breaking session at the 2025 American Academy of Dermatology Association (AAD) Annual Meeting in Orlando, Florida.
Patients treated with a 40 mg twice daily dose of ESK-001 demonstrated sustained or increasing clinical responses at Week 52 compared to Week 12 (using modified non-responder imputation, n=80). Improvements were measured by PASI 90 (61.3% vs. 52.4%), PASI 100 (38.8% vs. 26.8%), and sPGA 0 (38.8% vs. 32.9%). Additionally, patients reported significant control of itch (NRS≤4, 81.3%) and quality-of-life improvements (DLQI0/1, 61.3%). The treatment remained well tolerated at week 52, consistent with previously reported safety data.
“We are pleased to see ESK-001 demonstrating a favorable clinical profile for the potential treatment of moderate-to-severe plaque psoriasis,” stated Dr. Jörn Drappa, Alumis’ Chief Medical Officer. “We believe ESK-001 can address a critical need in psoriasis care with its well-tolerated oral delivery that may yield biologic-like clinical results.”
ESK-001 is specifically designed to restore immune balance by targeting proinflammatory mediators, including IL-23, IL-17, and type 1 interferon (IFN). This selective targeting seeks maximal efficacy while minimizing off-target impacts.
“These long-term findings reinforce ESK-001’s differentiated profile as a leading oral treatment for moderate-to-severe plaque psoriasis,” said Martin Babler, President and Chief Executive Officer of Alumis. “We are excited to continue enrolling patients in the pivotal Phase 3 ONWARD studies, with topline data expected in Q1 2026.”
About ESK-001
Alumis’ lead candidate, ESK-001, aims to address immune dysregulation in a variety of diseases influenced by inflammatory mediators, specifically targeting IL-23, IL-17, and type 1 interferon (IFN) to maximize treatment effectiveness while reducing off-target activity.
Alumis Launches ONWARD Trials to Test ESK-001 for Psoriasis
ONWARD2 is a new clinical trial aimed at assessing the safety and efficacy of ESK-001 in adults suffering from moderate-to-severe plaque psoriasis. This trial plans to enroll approximately 840 patients who will be randomly assigned in a 2:1:1 ratio to receive either ESK-001 at a dosage of 40 mg twice daily, a placebo, or apremilast. The primary efficacy endpoints will focus on the percentage of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and a score of 0/1 on the sPGA scale of ESK-001 compared to the placebo group at Week 16. Additionally, participants completing Week 24 may join a long-term extension trial (LTE) known as ONWARD3, which will further investigate the durability of treatment response and long-term safety.
The Phase 3 clinical program is bolstered by encouraging results from the Phase 2 STRIDE clinical trial (NCT05600036) as well as the ongoing long-term OLE extension (CT05739435). Interim data from the 28-week OLE presented at the 2024 European Academy of Dermatology & Venereology (EADV) Congress indicated a dose-dependent sustained improvement in all PASI scores over time. Notably, most patients taking the 40 mg twice daily dose achieved PASI 75. The safety profile of ESK-001 remained favorable during the OLE, with treatment-emergent adverse events (TEAEs) being consistent across all participant groups. The predominant side effects were upper respiratory tract infections, nasopharyngitis, and headaches, with most instances being mild to moderate and self-limiting.
Simultaneously, Alumis is working on a once-daily modified release oral version of ESK-001, which is intended to replace the existing immediate release formulation that requires dosing twice daily.
ESK-001 is also undergoing evaluation in LUMUS, a Phase 2b clinical trial targeting systemic lupus erythematosus patients. Furthermore, Alumis is utilizing its precision data analytics platform to study the potential uses of ESK-001 in other immune-mediated diseases.
About Alumis
Alumis is a clinical-stage biopharmaceutical company focused on developing oral therapies aimed at optimizing clinical outcomes for patients with immune-mediated diseases. Using its proprietary precision data analytics platform, the company is advancing a pipeline of therapeutic molecules that seek to address various immune-mediated conditions, either as standalone therapies or in combination. Currently, Alumis’ most advanced candidate, ESK-001, is a highly selective, small molecule, allosteric TYK2 inhibitor being assessed for the treatment of moderate-to-severe plaque psoriasis and systemic lupus erythematosus. The company is also developing A-005, another clinical-stage allosteric TYK2 inhibitor aimed at treating neuroinflammatory and neurodegenerative conditions. Beyond these therapies, Alumis’ proprietary platform and drug discovery capabilities have led to the identification of additional preclinical initiatives that reflect its precision development strategy. Founded by Foresite Labs, Alumis is led by a team of industry veterans with extensive experience in small-molecule drug development for immune-related disorders. More information is available at www.alumis.com.
Forward-Looking Statements
This press release includes forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These may be indicated by terms such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these terms that signify forward-looking information. Such statements are not historical facts but projections of Alumis’ future plans and prospects, including the progression and commercialization of its drug pipeline, the potential of ESK-001 as an effective oral treatment for psoriasis, and anticipated outcomes regarding the drug’s safety and efficacy. Readers should note that actual outcomes, levels of activity, safety, efficacy, performance, or circumstances may differ substantially from those indicated by the forward-looking statements in this release due to numerous risks and uncertainties, including those related to regulatory approvals, clinical trial results, funding capabilities, and intellectual property protection, among others. Alumis expressly disclaims any obligation to update these forward-looking statements unless required by law.
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