Oruka Therapeutics Shares Clinical Advancements for ORKA-001 Antibody

Exciting Developments at Oruka Therapeutics

Oruka Therapeutics, Inc. (Nasdaq: ORKA) is making significant strides in their development of innovative biologics aimed at transforming the treatment landscape for chronic skin diseases like plaque psoriasis (PsO). The company recently announced updated timelines for their lead candidates, ORKA-001 and ORKA-002, as they prepare to enter clinical studies.

ORKA-001: Leading the Way in Psoriasis Treatment

ORKA-001 is a novel half-life extended monoclonal antibody (mAb) that targets IL-23p19, and the first-in-human dosing is now anticipated to begin in the first quarter of 2025. This groundbreaking treatment aims to offer patients a more effective and convenient alternative to existing therapies, which often require multiple doses throughout the year.

Enhanced Efficacy and Dosing Convenience

Current IL-23p19 inhibitors are beneficial but typically require patients to be dosed four to six times a year, with less than half achieving full clearance after four months. ORKA-001 has the potential to dramatically simplify treatment by requiring just one or two doses annually. Such infrequent administration combined with higher antibody exposures could lead to improved outcomes, including enhanced rates of skin clearances.

Clinical Insights Expected in 2025 and 2026

Oruka Therapeutics plans to provide interim data from the first-in-human trials during the second half of 2025, followed by initial efficacy results in psoriasis patients by late 2026. This proactive approach showcases the commitment of Oruka to bring effective treatments to patients in need.

ORKA-002: Aiming for Dual Action Against Psoriasis

In addition to ORKA-001, Oruka is developing ORKA-002, another novel half-life extended mAb that targets IL-17A/F. The first-in-human dosing for ORKA-002 is set for the third quarter of 2025, providing a complementary option for patients, especially those suffering from concurrent psoriatic arthritis (PsA).

Potential for Broader Applications

The dual inhibition of IL-17A and IL-17F by ORKA-002 has demonstrated promise not just in psoriasis, but also other conditions such as hidradenitis suppurativa (HS) and axial spondyloarthritis (axSpA). With an aim to match established agents in terms of efficacy, ORKA-002 could redefine expectations for treatment regimens in these challenging diseases.

First Presentation of Preclinical Data at EADV

Oruka Therapeutics is set to present the first preclinical data for ORKA-001 at the upcoming European Academy of Dermatology and Venereology (EADV) Congress. This presentation will highlight the in vitro potency of ORKA-001 compared to benchmark antibodies, alongside pharmacokinetic data that reveals a remarkable half-life of over 30 days in non-human primates (NHPs).

Commitment to Patient Care and Innovation

Lawrence Klein, Chief Executive Officer of Oruka, expressed pride in the team’s progress, emphasizing the company’s dedication to providing more effective treatments for patients. He noted that the favorable pharmacokinetic profile found in NHPs raises expectations for the eventual human profile, potentially enabling extended dosing intervals that could significantly benefit patients.

About Oruka Therapeutics

At its core, Oruka Therapeutics is driven by a mission to redefine the standard of care for chronic skin diseases. By developing a proprietary portfolio of potentially best-in-class antibodies engineered to address the key mechanisms behind plaque psoriasis, the company aims to deliver high rates of complete disease clearance with much less frequent dosing. This vision is not just about addressing symptoms— it is about giving power back to patients and enhancing their quality of life.

Frequently Asked Questions

What are ORKA-001 and ORKA-002?

ORKA-001 and ORKA-002 are novel monoclonal antibodies developed by Oruka Therapeutics, targeting IL-23p19 and IL-17A/F respectively for the treatment of chronic skin diseases like psoriasis.

When is the clinical trial for ORKA-001 expected to start?

The clinical trial for ORKA-001 is expected to begin in the first quarter of 2025.

What advantages does ORKA-001 have over existing treatments?

ORKA-001 aims to provide more effective treatment with significantly less frequent dosing, only needing one or two doses annually compared to current therapies.

Where will the preclinical data on ORKA-001 be presented?

The preclinical data on ORKA-001 will be presented at the EADV Congress.

What is Oruka Therapeutics' primary mission?

Oruka Therapeutics is committed to developing innovative biologics that offer patients with chronic skin diseases like psoriasis increased freedom from their condition via effective treatments.

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