Core Insights - Oruka Therapeutics announced positive interim data from its Phase 1 trial of ORKA-002, indicating a half-life of 75-80 days, which supports potential dosing of twice a year for psoriasis and quarterly for hidradenitis suppurativa [1][6] - Phase 2 studies for ORKA-002 are expected to begin in the first half of 2026 for psoriasis and the second half of 2026 for hidradenitis suppurativa [1][4] - The first patients were dosed in the EVERLAST-B Phase 2b trial of ORKA-001 in December 2025, with data anticipated in 2027 [1][5] ORKA-002 Phase 1 Trial Findings - The Phase 1 trial was a randomized, double-blind, placebo-controlled study involving 24 healthy adult participants across three dosing cohorts: 160 mg, 320 mg, and 640 mg [3] - ORKA-002 demonstrated a half-life greater than three times that of bimekizumab, with a comparable Cmax at equivalent doses [6] - The safety profile of ORKA-002 was favorable, with no severe treatment-emergent adverse events reported [6] ORKA-002 Phase 2 Trials - ORCA-SURGE, a Phase 2 trial for ORKA-002 in moderate-to-severe psoriasis patients, is expected to start in the first half of 2026, aiming to enroll approximately 160 patients [6] - The primary endpoint for ORCA-SURGE will be PASI 100 at Week 16, with maintenance dosing evaluating the potential for twice-yearly administration [6] ORKA-001 Updates - The EVERLAST-B trial is evaluating three induction dose levels of ORKA-001, with data expected in 2027 [5][7] - The study design includes re-randomization for patients achieving PASI 100 at Week 28, testing the potential for yearly dosing and extended off-treatment remissions [7] Company Overview - Oruka Therapeutics is focused on developing novel biologics aimed at setting a new standard for chronic skin disease treatment, particularly plaque psoriasis [8] - The company's mission is to provide high rates of complete disease clearance with infrequent dosing, potentially as little as once or twice a year [8]
Oruka Therapeutics Announces Positive Interim Phase 1 Data for ORKA-002 and Initiation of EVERLAST-B Trial of ORKA-001