Oruka Therapeutics has expanded the development rights for its lead IL-23 program into inflammatory bowel disease while building a $1.1 billion cash position that management expects will fund operations through an anticipated BLA filing for ORKA-001.
The company amended its IL-23 license agreement with Paragon Therapeutics in May to include all therapeutic areas. The original agreement did not include inflammatory bowel disease. The expanded agreement allows Oruka to pursue ORKA-001, or combinations involving the drug, in IBD subject to certain restrictions on the timing of clinical trials.
ORKA-001 is currently being developed in moderate-to-severe plaque psoriasis. Earlier Phase 2a data showed that 63.5% of treated participants achieved PASI 100 at Week 16, while 83% achieved PASI 90 and 84% achieved IGA 0/1. Oruka expects Week 28 data at the end of Q3 2026 and 52-week data in December, which will help assess whether the therapy can support dosing only once or twice per year.
Oruka has also fully enrolled the 187-patient EVERLAST-B Phase 2b trial and plans to begin a Phase 3 ORKA-001 program in the first half of 2027.
The company is simultaneously expanding the broader pipeline. ORKA-004, a half-life extended monoclonal antibody targeting TL1A, is expected to enter clinical development during the fourth quarter of 2026. Oruka plans Phase 2 studies combining ORKA-004 with ORKA-001 and ORKA-002 beginning in 2027.
KEY QUOTE:
“With EVERLAST-B now fully enrolled and a Phase 3 program for ORKA-001 on the horizon, alongside the initiation of ORCA-SPLASH in HS, we are executing on our strategy to establish ORKA-001 and ORKA-002 as potentially best-in-class options across psoriatic disease and beyond.”
Lawrence Klein, Ph.D., CEO of Oruka Therapeutics
