Core Insights - Oruka Therapeutics is advancing its clinical trials for ORKA-002, a novel monoclonal antibody targeting IL-17A and IL-17F, with dosing of healthy volunteers initiated and pharmacokinetic data expected by the end of 2025 [1][2][5] - The company plans to start a Phase 2 study for ORKA-002 in moderate-to-severe psoriasis in the first half of 2026, focusing on safety and efficacy across multiple dosing regimens [3][4] Group 1: Clinical Development - ORKA-002 is currently in a Phase 1 trial, which is a double-blind, placebo-controlled study involving approximately 24 healthy volunteers [2][3] - Interim data from the Phase 1 trial is anticipated around the end of 2025, which will inform the subsequent Phase 2 study [2][3] Group 2: Product Differentiation - ORKA-002 has the potential to be dosed two to three times per year, significantly less frequent than current therapies, which typically require monthly dosing [5] - The dual inhibition of IL-17A and IL-17F by ORKA-002 is expected to provide superior efficacy compared to existing treatments that only target IL-17A [5] Group 3: Company Vision - Oruka Therapeutics aims to set a new standard for treating chronic skin diseases, particularly plaque psoriasis, by achieving high rates of complete disease clearance with infrequent dosing [6] - The company is focused on developing a proprietary portfolio of potentially best-in-class antibodies targeting the underlying mechanisms of chronic skin diseases [6]
Oruka Therapeutics Announces First Participants Dosed in Phase 1 Trial of ORKA-002, its Novel Half-life Extended Anti-IL-17A/F Antibody