Oruka Therapeutics has announced the initiation of its Phase 1 clinical trial for ORKA-001, a novel, subcutaneously administered monoclonal antibody targeting IL-23p19. This first-in-human study marks a significant step in the development of a potentially long-acting treatment for immune-mediated diseases.
The Phase 1 trial is designed to assess the safety and pharmacokinetic (PK) profile of ORKA-001 in healthy volunteers. Data from this study are expected to be available in the second half of 2025. The successful completion of this phase will pave the way for further clinical development in patient populations.
Planned Psoriasis Study
Oruka Therapeutics is planning to initiate a proof-of-concept study in patients with psoriasis in the second half of 2025. Initial efficacy data from this study are anticipated in the second half of 2026. Psoriasis, a chronic autoimmune disease affecting millions worldwide, represents a key target for ORKA-001.
Potential for Infrequent Dosing
Preclinical data indicate that ORKA-001 has the potential for significantly less frequent dosing compared to existing treatments, potentially requiring administration only once or twice per year. This could represent a substantial improvement in patient convenience and adherence, addressing a significant unmet need in the management of chronic inflammatory conditions. The current standard of care often involves more frequent injections or infusions, which can be burdensome for patients.
IL-23 is a key cytokine involved in the pathogenesis of several autoimmune diseases, including psoriasis, inflammatory bowel disease, and psoriatic arthritis. By selectively targeting the p19 subunit of IL-23, ORKA-001 aims to inhibit the IL-23 signaling pathway and reduce inflammation. The development of ORKA-001 reflects a growing trend towards targeted therapies that offer improved efficacy and safety profiles compared to traditional immunosuppressants.
