Oruka Therapeutics Begins Phase 1 Trial Of ORKA-002, A Long-Acting IL-17A/F Antibody For Psoriasis, With First Participants Dosed

Oruka Therapeutics, Inc., a biotechnology company focused on developing innovative biologics for the treatment of chronic skin diseases such as plaque psoriasis, announced the initiation of dosing in its first clinical trial of ORKA-002. ORKA-002 is a novel monoclonal antibody designed for subcutaneous administration and engineered to have an extended half-life. It targets both IL-17A and IL-17F, two key cytokines involved in the inflammatory pathways of psoriasis. The Phase 1 clinical trial is a double-blind, placebo-controlled, single ascending dose study that aims to evaluate the safety, tolerability, and pharmacokinetics of ORKA-002. 

Lawrence Klein, PhD, Chief Executive Officer of Oruka, said in a statement, “With both ORKA-001 and ORKA-002 now in human trials, we are moving quickly to demonstrate the clinical differentiation of both assets. Bimekizumab is launching extremely well as IL-17A/F has emerged as superior to IL-17A inhibition in several important indications. Uniquely, we could have the best targeting approaches for both IL-23p19 and IL-17A/F, potentially allowing us to offer the ideal regimen to patients through our ORKA-001 and -002 monotherapies and our ORKA-021 sequential combination.”

Joana Goncalves, MBChB, Chief Medical Officer of Oruka, stated, “ORKA-002 has the opportunity to become the best antibody in the IL-17 class, which is preferred when treating psoriasis with joint involvement or recalcitrant skin disease, as well as psoriatic arthritis, hidradenitis suppurativa, and beyond. With this program now in the clinic, we are one step closer to our goal of offering the most possible freedom from disease to patients with psoriasis and other conditions.”

The trial will enroll approximately 24 healthy volunteers, divided into three cohorts receiving increasing subcutaneous doses of the investigational therapy. Oruka expects to share interim data from this study by the end of 2025. Based on the results of the Phase 1 trial, the company plans to initiate a Phase 2 study in the first half of 2026. The Phase 2 trial will be conducted in patients with moderate-to-severe plaque psoriasis and is designed to assess the safety and efficacy of multiple dosing regimens of ORKA-002. The primary endpoint of the study will be the proportion of patients achieving PASI 100, or complete skin clearance, at week 16.