Oruka Therapeutics Announces Preclinical Data for ORKA-002 at the 2025 American Academy of Dermatology Annual Meeting

Half-life in non-human primates (NHP) of more than 30 days, over three times longer than bimekizumab and expected to support a dose interval of two to three times per year

Equivalent potency to bimekizumab with similar binding affinity and epitope demonstrated in several preclinical assays

First subject dosed with ORKA-002 expected in Q3 2025

MENLO PARK, Calif., March 07, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced new preclinical data on ORKA-002, a novel extended half-life monoclonal antibody targeting IL-17A/F, from its presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting.

• ORKA-002 has an NHP half-life of more than 30 days following subcutaneous and intravenous administration, over three times longer than bimekizumab. Projections of ORKA-002 pharmacokinetics (PK) in humans indicate that a human half-life of approximately 50 days could enable dosing once every four months, while a human half-life of approximately 75 days could enable twice-yearly dosing. The NHP half-life observed for ORKA-002 supports the potential to achieve these extended dosing intervals given that other YTE-modified antibodies have had an approximately two to four times longer half-life in humans than in NHPs.
• ORKA-002 binds to a similar epitope with similar affinity to bimekizumab and shows equivalent potency across a variety of in vitro assays. ORKA-002 binds IL-17A and IL-17F with a comparable picomolar affinity as bimekizumab. Based on cryo-EM structural analysis, ORKA-002 binds to a nearly identical epitope to bimekizumab on both IL-17A and IL-17F. When assessed across multiple different assays in cell lines and primary cells, ORKA-002 also had comparable functional potency for IL-17A and IL-17F antagonism. These findings further derisk the development path for ORKA-002.

“We are highly encouraged by the exceptional properties of ORKA-002, including a half-life in NHPs that is, for the second time in two programs, one of the longest seen to date for any antibody,” said Lawrence Klein, Oruka’s Chief Executive Officer. “Bimekizumab has had a remarkable launch, showing the excitement around IL-17A/F inhibition. We believe ORKA-002 could offer an even better product profile to people with psoriasis, psoriatic arthritis, and additional indications.”

About ORKA-002

ORKA-002 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A/F. Dual inhibition of both IL-17A and IL-17F has shown superior efficacy compared to IL-17A inhibition alone in psoriasis (PsO) and other indications, as shown by the performance of Bimzelx (bimekizumab) compared to Cosentyx (secukinumab) and Taltz (ixekizumab) in Phase 3 trials. These therapies all utilize monthly maintenance dosing in PsO and psoriatic arthritis (PsA), except Bimzelx in PsO patients weighing