Oruka Therapeutics’ ORKA-001 achieves 63.5% complete skin clearance at week 16
Oruka Therapeutics’ ORKA-001 achieved complete skin clearance in 63.5% of EVERLAST-A participants (40 of 63) at week 16, versus one of 21 on placebo. Secondary endpoints showed 83% reaching PASI 90 and 84% achieving IGA 0/1, with a safety profile comparable to placebo.
1. Phase 2a efficacy results
Oruka Therapeutics reported that 63.5% of EVERLAST-A participants (40 of 63) treated with ORKA-001 achieved PASI 100 complete skin clearance at week 16 versus one of 21 placebo recipients. Secondary outcomes showed 83% reached PASI 90 and 84% achieved IGA 0/1.
2. Safety profile
No serious treatment-related adverse events were observed, and overall safety was similar to placebo (51% vs 57% any adverse events). Upper respiratory infections were most common, affecting 19% of treated patients versus 14% in the placebo group, and there were no injection site reactions.
3. Pharmacokinetic data support annual dosing
Updated Phase 1 data demonstrated that a single 600 mg dose maintained therapeutic drug levels for 12 months, supporting the potential for once-yearly ORKA-001 dosing.
4. Future development plans and stock reaction
Oruka plans to present week 28 and 52 follow-up data in H2 2026, and its Phase 2b EVERLAST-B trial enrolling roughly 160 patients is slated to report results in 2027; ORKA stock jumped 32% in premarket trading.