Oruka Therapeutics Reports Positive Week 28 Data for ORKA-001
News related to:Oruka Therapeutics · 2 min read
Oruka Therapeutics, a clinical-stage biotechnology company developing novel biologics for chronic skin diseases, announced positive Week 28 results from its EVERLAST-A Phase 2a trial of ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody, in moderate-to-severe plaque psoriasis. The data showed that PASI 100 increased to 71.4% and PASI 90 increased to 87.3%, despite no dosing after Week 4. These results indicate that responses continued to deepen months after the last dose.
The EVERLAST-A trial, conducted across 26 sites in the United States and Canada, enrolled 84 patients randomized 3:1 to receive 600 mg of ORKA-001 at Week 0 and 4 or matching placebo. Patients who initially received placebo were given 600 mg of ORKA-001 at Week 16 and 20. The study continues through Week 52 to assess durability of response, maintenance dosing, and long-term safety.
Efficacy data showed that 63.5% of patients (40 of 63) treated with ORKA-001 achieved the primary endpoint of PASI 100 at Week 16. Clinical responses continued to deepen through Week 28, with PASI 100 response rates increasing to 71.4% (45 of 63) and PASI 90 response rates increasing to 87.3% (55 of 63) at Week 28. IGA 0/1 response rates were maintained at 84.1% (53 of 63).
Patients who initially received placebo and crossed over to ORKA-001 at Week 16 demonstrated a similar pattern of clinical response. In this dosing arm, 40.0% (8 of 20) achieved PASI 100 at Week 28 (12 weeks after dosing), compared to 42.9% (27 of 63) of patients in the active arm at the equivalent timepoint.
Safety data indicated that ORKA-001 continues to be well tolerated, with a safety profile consistent with the IL-23p19 class. Between Weeks 16-28, the only treatment-emergent adverse event in ≥5% of patients receiving ORKA-001 was an upper respiratory tract infection, occurring in 8% (7 of 83) of patients. Two patients experienced serious adverse events, neither deemed drug related: one tibial fracture and one case of prostate adenocarcinoma in a patient with elevated prostate-specific antigen (PSA) at baseline. There continue to be no injection site reactions. No impact of anti-drug antibodies on safety, efficacy, or pharmacokinetics has been observed.
Oruka plans to share longer-term data from EVERLAST-A, including efficacy at Week 52 for all patients, in December 2026. The company also continues to advance the EVERLAST-B Phase 2b trial of ORKA-001, with data expected during the fourth quarter of 2026.