MENLO PARK, Calif. — September 17, 2025 — Leads & Copy — Oruka Therapeutics, Inc. (Nasdaq: ORKA) has announced interim data from its Phase 1 trial of ORKA-001, the Company’s long-acting IL-23p19 antibody, in a late-breaking abstract at the European Academy of Dermatology and Venerology (EADV) Congress in Paris, France.
The Phase 1 trial’s interim results support ORKA-001’s potential to change the PsO treatment paradigm, with the ongoing EVERLAST-A Phase 2a trial designed to test whether ORKA-001 can enable annual dosing, higher rates of skin clearance than standard of care, and long-term off-treatment remissions. The company expects to present initial data from EVERLAST-A in 2H 2026.
ORKA-001 showed a half-life of approximately 100 days, and single doses of ORKA-001 demonstrated complete and sustained inhibition of STAT3 signaling, a downstream marker of IL-23 activity, in an ex vivo assay through 24 weeks. ORKA-001 was well tolerated at all dose levels, with a favorable safety profile consistent with the anti-IL-23 class.
“ORKA-001’s approximately 100-day half-life exceeded our expectations and has the potential to enable multiple ‘upside’ scenarios for the program,” said Lawrence Klein, PhD, CEO of Oruka.
The oral presentations at EADV are: Phase 1 Clinical Data of ORKA-001, a Novel Half-Life Extended IL-23p19 Monoclonal Antibody with Potential for Once-Yearly Dosing in Plaque Psoriasis and EVERLAST-A: A Phase 2a Study Design of ORKA-001, a Novel Half-Life Extended IL-23p19 Monoclonal Antibody for Plaque Psoriasis
Investor Contact: Alan Lada, (650)-606-7911, alan.lada@orukatx.com
Source: Oruka Therapeutics
