Oruka Therapeutics Begins Phase 1 Trial Dosing for ORKA-001 Antibody

Oruka Therapeutics, Inc., a biotechnology company based in Menlo Park, California, has announced the commencement of its first clinical trial of ORKA-001, a novel biologic designed to treat chronic skin conditions like plaque psoriasis. This subcutaneously administered monoclonal antibody targets IL-23p19 and boasts an extended half-life, representing a potential advancement over existing treatments.

The Phase 1 trial of ORKA-001 is a crucial step for Oruka, marking an important milestone in its development. Dr. Lawrence Klein, CEO of Oruka, expressed enthusiasm about the trial's initiation, which was achieved ahead of schedule. The company plans to release initial pharmacokinetic and safety data from healthy volunteers in the latter half of 2025, which could confirm the biologic's extended half-life and safety profile, supporting less frequent dosing schedules.

This Phase 1 study is structured as a double-blind, placebo-controlled, single ascending dose trial, evaluating both safety and tolerability. Approximately 24 healthy volunteers will participate, divided into three subcutaneous dose cohorts. Oruka anticipates sharing interim results from this study in the second half of 2025.

Following the Phase 1 trial results, Oruka intends to launch a proof-of-concept study targeting moderate-to-severe psoriasis in the latter half of 2025. This study will assess the safety and efficacy of ORKA-001 at a single dose level compared to a placebo in around 80 subjects. After initial treatment, participants will be randomized into two maintenance arms to explore the duration of clear skin maintenance—one receiving ORKA-001 every six months and another receiving only induction dosing. Insights from this study are expected in the second half of 2026.

Dr. Joana Goncalves, Oruka’s Chief Medical Officer, emphasized ORKA-001's potential to redefine treatment standards for plaque psoriasis by offering extended periods of disease remission. The company believes that addressing patients' desire for freedom from psoriasis symptoms aligns with its mission.

In addition to advancing ORKA-001, Oruka has secured a licensing agreement with Paragon Therapeutics, granting it exclusive global rights to ORKA-001 for all conditions except inflammatory bowel disease. This partnership aims to bolster Oruka's innovative approach to dermatologic and inflammatory disease treatments.

ORKA-001 stands out in the therapeutic landscape as a half-life extended monoclonal antibody that targets IL-23p19. Current IL-23p19 inhibitors, which are the preferred initial treatment for moderate-to-severe psoriasis, require multiple doses annually. However, ORKA-001 promises to reduce this frequency to once or twice a year while potentially achieving higher skin clearance rates. Preclinical studies, including non-human primate assays, indicate that ORKA-001 binds similarly to risankizumab but with a significantly prolonged half-life, more than three times longer.

Oruka Therapeutics is committed to developing groundbreaking biologics that offer significant improvements in treating chronic skin diseases. Its goal is to provide patients with severe skin conditions, such as plaque psoriasis, the highest degree of relief with minimal dosing frequency. Through its proprietary portfolio of potential best-in-class antibodies, engineered by Paragon Therapeutics, Oruka aims to target the core mechanisms of these diseases. The company's dedication to innovation keeps it at the forefront of dermatological science, with ORKA-001 as a promising advancement in their pipeline.