Alumis Inc. announced today that it will present comprehensive Phase 2 data for ESK-001, its next-generation oral tyrosine kinase 2 (TYK2) inhibitor, at the upcoming American Academy of Dermatology (AAD) annual meeting in Orlando, Florida. The presentations will include long-term safety and efficacy data from the 52-week open-label extension study in patients with moderate-to-severe plaque psoriasis.
Key Clinical Findings and Program Updates
The company's research program will be featured in four presentations at AAD, including a late-breaking oral presentation highlighting the long-term Phase 2 results. The data package will encompass patient-reported outcomes, disease biomarker activity, and pharmacokinetic data, providing a comprehensive view of ESK-001's clinical profile.
Martin Babler, President and Chief Executive Officer of Alumis, expressed enthusiasm about the upcoming presentations, noting, "We are pleased to have these Phase 2 OLE data for ESK-001 selected for late-breaking oral and e-poster presentations at the annual AAD meeting and the opportunity to share these important results with the dermatology community."
Accelerated Development Timeline
In a significant development, Alumis has announced an accelerated timeline for its Phase 3 ONWARD program, with topline data now expected in Q1 2026. This acceleration reflects robust patient enrollment and strong investigator interest in the clinical program.
Phase 3 ONWARD Program Design
The ONWARD program consists of two parallel Phase 3 trials, ONWARD1 and ONWARD2, each enrolling approximately 840 patients. The studies will evaluate ESK-001 against both placebo and apremilast, with patients randomized in a 2:1:1 ratio. The primary endpoints focus on achieving PASI 75 and sPGA score 0/1 at Week 16.
Promising Interim Results
Earlier interim data from the 28-week open-label extension study, presented at the 2024 European Academy of Dermatology & Venereology Congress, showed encouraging results. Patients receiving the 40mg twice-daily dose demonstrated sustained improvements in PASI scores, with the majority achieving PASI 75. The drug maintained a favorable safety profile, with most adverse events being mild to moderate and self-limiting.
Therapeutic Innovation
ESK-001 represents a novel approach to treating immune-mediated diseases through selective TYK2 inhibition. The drug is designed to modulate key inflammatory pathways involving IL-23, IL-17, and type 1 interferon while minimizing off-target effects. Alumis is also developing a once-daily modified release formulation to potentially improve patient convenience.
Broader Development Program
Beyond psoriasis, ESK-001 is being evaluated in the LUMUS Phase 2b trial for systemic lupus erythematosus, demonstrating Alumis's commitment to exploring the drug's potential across multiple autoimmune conditions. The company continues to leverage its precision data analytics platform to identify additional therapeutic applications for ESK-001.
