Oruka Therapeutics (NASDAQ:ORKA) announced positive interim results from its EVERLAST-A Phase 2a trial on Monday, April 27, 2026.
The study evaluated ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody, in patients with moderate-to-severe plaque psoriasis, yielding efficacy data that management described as reaching the "top end" of expectations.
The randomized, double-blind study enrolled 84 patients across 26 sites in the U.S. and Canada.
Patients received a 600 mg dose of ORKA-001 at Weeks 0 and 4.
At the primary endpoint of Week 16, 63.5% of participants treated with ORKA-001 achieved PASI 100, representing complete skin clearance, compared to just one participant in the placebo group.
Additionally, 83% of treated patients achieved PASI 90.
These figures are numerically higher than results reported for existing IL-23p19 inhibitors and rival the highest clearance rates ever reported in plaque psoriasis trials.
The safety profile of ORKA-001 was consistent with the IL-23 class, with no serious treatment-emergent adverse events (TEAEs) reported in the treatment group.
Most side effects were mild, with upper respiratory tract infections being the most common.
Crucially, updated pharmacokinetic data continues to support the drug's potential for annual or semi-annual dosing; concentrations of the antibody remained above effective trough levels for a full year following a single dose.
Oruka plans to present longer-term follow-up data, including 52-week results for a subset of the cohort, in the second half of 2026.
The company is also currently advancing its Phase 2b EVERLAST-B trial, with topline data anticipated in 2027.