Oruka Therapeutics, Inc. (ORKA) reported that its psoriasis therapy ORKA-001 achieved complete skin clearance in 63.5% of treated patients at Week 16, according to new interim data from the ongoing EVERLAST-A Phase 2a trial.
The company said the results reached the "top end" of expectations for efficacy, tolerability, and durability.
Plaque psoriasis is a chronic inflammatory skin disease that can significantly affect quality of life. While several IL-23p19 inhibitors are already approved, Oruka is developing ORKA-001 as a half-life-extended antibody that may allow dosing as infrequently as once or twice per year- an approach aimed at reducing treatment burden for patients.
Strong efficacy signals in early-stage testing
EVERLAST-A is a randomized, double-blind, placebo-controlled Phase 2a study evaluating ORKA-001 in moderate-to-severe plaque psoriasis across 26 sites in the U.S. and Canada. Among 63 patients treated with ORKA-001, 40 achieved the primary endpoint of PASI 100- complete skin clearance- at Week 16. Identical results were observed for IGA 0, another measure of full clearance. Only one of 21 placebo-treated patients reached PASI 100.
Secondary endpoints also showed high response rates, including PASI 90 (83%) and IGA 0/1 (84%). Based on cross-trial comparisons, Oruka said the results appear numerically higher than those reported for other IL-23p19 inhibitors.
Safety profile consistent with IL-23p19 class
ORKA-001 was well tolerated, with no serious treatment-emergent adverse events reported. The overall rate of side effects was similar between the treatment and placebo groups, and the only event occurring in 5% or more of participants was upper respiratory tract infection. No injection-site reactions were observed.
Once-yearly dosing potential
Updated pharmacokinetic and pharmacodynamic data from the Phase 1 study continue to support the possibility of annual dosing. A single 600 mg dose-maintained drug levels above the effective threshold for a full year, with sustained IL-23 pathway inhibition and no impact from anti-drug antibodies.
Upcoming milestones
Oruka plans to share longer-term EVERLAST-A data- including Week 28 results and 52-week follow-up for a subset of patients- in the second half of 2026. The company is also advancing the Phase 2b EVERLAST-B trial, with data expected in 2027.
We last updated our readers on September 18, 2025, when the stock was trading at $16.21.
ORKA has traded between $8.91 and $71.00 over the past year. The stock closed Friday's (April 24, 2026) trading at $69.03, up 1.90%. In pre-market trading, the stock is at $83.00 up 20.24%.
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