Core Insights - Oruka Therapeutics has announced interim data from its Phase 1 trial of ORKA-001, a long-acting IL-23p19 antibody, which shows a half-life of approximately 100 days, supporting the potential for once-per-year dosing and higher efficacy in treating plaque psoriasis [1][2][4] - The ongoing EVERLAST-A Phase 2a trial aims to evaluate the safety and efficacy of ORKA-001 in moderate-to-severe psoriasis patients, with initial data expected in the second half of 2026 [1][3][5] Group 1: Phase 1 Trial Findings - The Phase 1 trial was a randomized, double-blind, placebo-controlled study involving 24 healthy adult participants, assessing the safety and pharmacokinetics of ORKA-001 [3] - Interim results indicate that ORKA-001 demonstrated a favorable safety profile, with no severe treatment-emergent adverse events reported [4] - The pharmacokinetic profile of ORKA-001 showed a half-life greater than three times that of risankizumab, suggesting potential for best-in-class rates of skin clearance [4] Group 2: Phase 2 Trials and Future Plans - The EVERLAST-A trial will enroll approximately 80 patients, randomized to receive either ORKA-001 or placebo, with the primary endpoint being PASI 100 at Week 16 [9] - A dose-ranging Phase 2b trial, EVERLAST-B, is expected to begin in the first half of 2026, evaluating three dose levels of ORKA-001 against placebo [5] - The design of the EVERLAST-A trial includes a follow-up at Week 28 to assess the potential for extended off-treatment remissions [9] Group 3: Product Overview - ORKA-001 is a novel monoclonal antibody targeting IL-23p19, designed for subcutaneous administration with a significantly extended half-life [7] - The product aims to achieve higher rates of disease clearance and extended off-treatment remissions compared to currently marketed IL-23p19 antibodies, which require more frequent dosing [7] - The company is focused on setting a new standard for the treatment of chronic skin diseases, particularly plaque psoriasis, with the goal of achieving high rates of complete disease clearance [8]