Oruka Therapeutics (NASDAQ:ORKA) has announced the initiation of dosing of in its Phase 1 clinical trial of ORKA-001, a subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19.
Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe psoriasis given their strong efficacy and safety profile. Oruka expects pharmacokinetic (PK) and safety data in the second half of 2025 and states it is on track to initiate a proof-of-concept study in psoriasis at that time.
“The initiation of this Phase 1 study of ORKA-001 marks an important milestone for Oruka, which our team has delivered ahead of schedule,” said Lawrence Klein, PhD, CEO of Oruka.
“We look forward to sharing initial data for ORKA-001 in the second half of 2025, which could validate ORKA-001’s half-life and safety profile, supporting extended dosing intervals and best-in-class potential,” Dr. Klein added.
Joana Goncalves, MBChB, CMO of Oruka, said, “We believe that ORKA-001 has the potential to set a new standard in the treatment of plaque psoriasis in terms of both depth and duration of response. We hear consistently that people with psoriasis want to achieve freedom from their disease, and that is what we hope to offer with this program. The initiation of this Phase 1 study brings us one step closer to that goal.”
