Menlo Park, Calif., December 19, 2024— Oruka Therapeutics (Nasdaq: ORKA), a biotechnology company focused on innovative biologics for chronic skin conditions, has announced the initiation of dosing in its Phase 1 clinical trial of ORKA-001. This novel monoclonal antibody targets IL-23p19, a key protein implicated in chronic skin diseases such as plaque psoriasis. The study will assess the safety, tolerability, and pharmacokinetics of ORKA-001 in healthy volunteers.
The Phase 1 trial will involve 24 participants, divided into three subcutaneous dose cohorts. Oruka expects to release preliminary data in the second half of 2025, which will provide insights into the antibody’s half-life and safety profile, and its potential for extended dosing intervals.
“We are excited to begin dosing in our Phase 1 trial of ORKA-001, ahead of schedule,” said Dr. Lawrence Klein, CEO of Oruka Therapeutics. “We look forward to sharing initial data by mid-2025, which will help determine the antibody’s suitability for less frequent dosing, reinforcing its potential as a best-in-class treatment for chronic skin conditions.”
Next Steps and Proof-of-Concept Study
Pending the results of the Phase 1 trial, Oruka plans to launch a proof-of-concept study in moderate-to-severe psoriasis in late 2025. This study will evaluate a single dose of ORKA-001 against a placebo in approximately 80 participants. Following the initial dose, patients will be randomized into two maintenance arms: one will receive ORKA-001 every six months, while the other will only receive an initial dose to assess how long patients maintain clear skin, potentially paving the way for once-yearly dosing or longer-term durability.
“We believe ORKA-001 could redefine how we treat plaque psoriasis, offering patients not only deeper but longer-lasting disease remission,” said Dr. Joana Goncalves, Chief Medical Officer of Oruka Therapeutics. “Psoriasis patients consistently tell us they seek greater freedom from their disease, and we aim to deliver that with ORKA-001.”
The company anticipates sharing initial data from this proof-of-concept trial in the second half of 2026.
Exclusive License Agreement with Paragon Therapeutics
In a related development, Oruka has entered into a worldwide exclusive license agreement with Paragon Therapeutics for the rights to ORKA-001 in all indications except for inflammatory bowel disease. This partnership strengthens Oruka’s pipeline, positioning ORKA-001 as a potential breakthrough treatment for chronic skin conditions.
About ORKA-001
ORKA-001 is a subcutaneously administered, half-life extended monoclonal antibody designed to target IL-23p19. IL-23p19 inhibitors have become a cornerstone of treatment for moderate-to-severe psoriasis, offering strong efficacy and safety. However, current therapies require frequent dosing, typically four to six times per year, with less than half of patients achieving complete skin clearance after four months.
In contrast, ORKA-001 is designed for less frequent administration, potentially just once or twice a year, while achieving higher exposure levels than existing IL-23p19 inhibitors. Preclinical data suggest that ORKA-001 binds to a similar epitope as risankizumab but boasts a half-life more than three times longer, potentially offering enhanced disease clearance.
About Oruka Therapeutics
Oruka Therapeutics is committed to developing innovative biologics that set a new standard for treating chronic skin diseases. The company’s mission is to provide patients with the freedom to live without the constant burden of conditions like plaque psoriasis, through therapies that offer high rates of disease clearance with infrequent dosing. Oruka is advancing a proprietary portfolio of engineered antibodies targeting the core mechanisms of dermatologic and inflammatory diseases. For more information, visit orukatxand follow Oruka on LinkedIn.
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