Core Insights - Oruka Therapeutics has initiated dosing of healthy volunteers in its first clinical trial of ORKA-001, a novel monoclonal antibody targeting IL-23p19, with pharmacokinetic and safety data expected in the second half of 2025 [1][2] - The company plans to start a proof-of-concept study for ORKA-001 in moderate-to-severe psoriasis in the second half of 2025, with initial efficacy data anticipated in the second half of 2026 [3][4] Company Developments - The Phase 1 trial of ORKA-001 is a double-blind, placebo-controlled study involving approximately 24 healthy volunteers across three dosing cohorts, with interim data expected in the second half of 2025 [2][3] - ORKA-001 is designed for once- or twice-yearly dosing, significantly improving upon current therapies that require four to six doses per year [5][7] - The company has entered into a license agreement with Paragon Therapeutics for worldwide exclusive rights to ORKA-001, excluding inflammatory bowel disease [4] Product Information - ORKA-001 is a half-life extended monoclonal antibody that has shown potential for higher disease clearance rates compared to currently marketed IL-23p19 antibodies, which achieve fully clear skin in less than half of patients after four months [5][7] - Preclinical data indicates that ORKA-001 binds to a similar epitope as risankizumab but has a significantly extended half-life, over three times longer than risankizumab [5]
Oruka Therapeutics Announces First Participants Dosed in Phase 1 Trial of ORKA-001, its Novel Half-life Extended Anti-IL-23p19 Antibody