Oruka Therapeutics

Oruka Therapeutics, a clinical-stage biopharmaceutical company, is focused on developing novel biologic therapies for chronic skin diseases, with a primary emphasis on plaque psoriasis and psoriatic arthritis. The company emerged in 2024 as the third spin-out from Paragon Therapeutics, a biotech incubator founded by healthcare investor Fairmount. Oruka's establishment was marked by a significant entrance into the public market through a reverse merger with ARCA biopharma, a transaction that occurred in September 2024. This strategic maneuver was coupled with substantial private financing, raising over $475 million in 2024, which is expected to fund operations through 2027.

The company's leadership team is headed by Chief Executive Officer Lawrence Klein, PhD, who previously served as an executive at CRISPR Therapeutics. His experience is complemented by a team of seasoned professionals in drug development. The company's business model is centered on advancing its pipeline of antibody-based therapeutics, discovered and engineered by Paragon Therapeutics. Oruka's strategy targets validated biological pathways in inflammatory diseases to create treatments with improved efficacy and more convenient dosing schedules for patients. The primary market is the expansive global population suffering from psoriasis, estimated at 125 million people, and the significant subset who develop psoriatic arthritis. The business generates value by developing these assets through clinical trials with the ultimate goal of commercialization.

Oruka's product pipeline features two co-lead programs, ORKA-001 and ORKA-002. ORKA-001 is a monoclonal antibody that targets the IL-23p19 subunit, a key cytokine in psoriasis pathogenesis. It has been engineered for an extended half-life, which has the potential to allow for dosing as infrequently as once or twice a year, a considerable reduction from the multiple annual doses required by current treatments. Phase 1 clinical trials for ORKA-001 began in late 2024, with a Phase 2 study planned for the second half of 2025. ORKA-002 is a monoclonal antibody targeting both IL-17A and IL-17F, cytokines involved in inflammation. This product is also designed for extended dosing intervals, potentially two to three times per year, and is being evaluated for plaque psoriasis and psoriatic arthritis. The company has initiated a Phase 1 trial for ORKA-002 and anticipates beginning a Phase 2 study in early 2026. Both programs aim to provide higher rates of complete skin clearance and durable remission for patients.

Keywords: biologics, plaque psoriasis, psoriatic arthritis, monoclonal antibodies, antibody engineering, dermatology, IL-23p19 inhibitor, IL-17A/F inhibitor, clinical-stage, biopharmaceutical