Core Insights - Alumis Inc. has completed patient enrollment in its pivotal Phase 3 ONWARD clinical program for ESK-001, targeting moderate-to-severe plaque psoriasis, with over 1,700 patients enrolled [2][4] - Topline results are expected to be reported in early Q1 2026, indicating progress towards providing new treatment options for patients [1][2] - ESK-001 is a next-generation oral TYK2 inhibitor designed to address immune dysregulation in various diseases, including plaque psoriasis [3][7] Clinical Program Details - The ONWARD clinical program consists of two parallel global Phase 3 trials, ONWARD1 and ONWARD2, each lasting 24 weeks and designed to evaluate the efficacy and safety of ESK-001 [4][5] - Patients are randomized in a 2:1:1 ratio to receive either ESK-001 40 mg twice daily, placebo, or apremilast, with co-primary endpoints focusing on the Psoriasis Area and Severity Index (PASI 75) and sPGA score [4][5] - An optional long-term extension trial, ONWARD3, is ongoing to assess the durability and long-term safety of ESK-001 for patients completing Week 24 [5] Product Profile - ESK-001 is characterized as a highly selective oral TYK2 inhibitor, aiming to minimize off-target effects while providing effective treatment for immune-mediated diseases [3][7] - The drug's development is supported by positive data from the Phase 2 STRIDE clinical trial and ongoing long-term open-label extensions [5] Broader Development Pipeline - Alumis is also exploring ESK-001's potential in other immune-mediated conditions, including a Phase 2b trial for systemic lupus erythematosus [6][7] - The company is developing a once-daily modified-release formulation of ESK-001 to enhance patient convenience compared to the current twice-daily regimen [5]
Alumis Completes Enrollment of Pivotal Phase 3 ONWARD Clinical Program of Lead Candidate ESK-001, a Highly Selective, Next-Generation Oral TYK2 Inhibitor for the Treatment of Moderate-to-Severe Plaque Psoriasis