Oruka Therapeutics has started dosing healthy volunteers in a Phase 1 clinical trial for ORKA-002, a novel subcutaneous monoclonal antibody targeting IL-17A/F for chronic skin diseases like psoriasis. The company anticipates interim data from this trial by the end of 2025 and plans to initiate a Phase 2 study in the first half of 2026. Preclinical data suggest ORKA-002 could potentially be administered only two to three times per year, a significant improvement over the current monthly dosing standard for similar treatments.
This development is notable because it marks a critical step toward validating ORKA-002’s extended half-life, a key differentiator in the competitive IL-17A/F inhibitor landscape. A less frequent dosing regimen could significantly improve patient compliance and quality of life, potentially positioning ORKA-002 as a preferred treatment option. This also represents progress for Oruka, demonstrating its capability to translate promising preclinical research into clinical development.
The Phase 1 trial is a placebo-controlled, single ascending dose study assessing safety, tolerability, and pharmacokinetics in approximately 24 healthy volunteers. The subsequent Phase 2 study, planned for the first half of 2026, will evaluate the safety and efficacy of ORKA-002 in patients with moderate-to-severe psoriasis, with PASI 100 at week 16 as the primary endpoint. Preclinical data indicates ORKA-002 possesses a significantly longer half-life than existing IL-17A/F inhibitors like bimekizumab.
The initiation of this Phase 1 trial sets the stage for potentially disruptive change in the treatment paradigm for psoriasis and other related conditions. Positive clinical data could validate ORKA-002’s potential to offer a best-in-class treatment profile, ultimately leading to improved patient outcomes and potentially reshaping the market dynamics within the IL-17 inhibitor class.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
