ORKA · Oruka Therapeutics, Inc.

Oruka Therapeutics reported positive Week 16 results from its Phase 2a EVERLAST-A trial of ORKA-001, a half-life extended anti-IL-23p19 antibody, in moderate-to-severe plaque psoriasis. The trial met its primary endpoint with 63.5% (40/63) of patients achieving PASI 100 (complete skin clearance) compared to 4.8% (1/21) for placebo (p<0.0001). Key secondary endpoints included 83% PASI 90 and 84% IGA 0/1. Safety was favorable, with no serious TEAEs in the ORKA-001 arm and TEAE rates comparable to placebo (51% vs 57%). Updated Phase 1 PK/PD data showed sustained drug levels and IL-23 pathway inhibition for 52 weeks after a single 600 mg dose, supporting annual dosing. The company plans to report longer-term durability data from EVERLAST-A in the second half of 2026 and is advancing the Phase 2b EVERLAST-B dose-ranging trial, with data expected in 2027. These results position ORKA-001 as a potential best-in-class therapy with high efficacy and infrequent dosing.