Oruka's ORKA-001 Posts Deepening Skin Clearance in Phase 2a Psoriasis Trial
核心洞察
Oruka Therapeutics (搜索) reported week 28 results from its Phase 2a trial of ORKA-001 in moderate-to-severe plaque psoriasis (搜索), with PASI 100 rising from 63.5% at week 16 to 71.4%.
PASI 90 response rates climbed to 87.3% and IGA 0/1 was maintained at 84.1%, indicating responses continued to deepen six months after the final dose.
Placebo crossover patients showed a similar trajectory, with 40% achieving PASI 100 twelve weeks after their first active dose, aligning with the active arm at the equivalent timepoint.
Oruka Therapeutics (搜索) reported positive week 28 outcomes from its Phase 2a clinical trial of ORKA-001 in moderate-to-severe plaque psoriasis (搜索), with patient responses continuing to improve six months after the final dose of the novel antibody. The company said the deepening of clinical benefit was observed across multiple efficacy measures in the treated population.
Efficacy Deepens Between Weeks 16 and 28
At week 16, 63.5% of treated patients achieved complete skin clearance, defined as PASI 100. By week 28, the PASI 100 response rate had risen to 71.4%, while PASI 90 responses climbed to 87.3%. The trial also maintained IGA 0/1 response rates at 84.1%.
Patients who transitioned from the placebo group to active drug at weeks 16 and 20 showed a similar pattern of improvement. Twelve weeks after their initial dose, 40% of these crossover patients achieved PASI 100, closely aligning with the active arm at the equivalent timepoint.
Safety Consistent With the IL-23p19 Class
ORKA-001 remained well tolerated, with a safety profile consistent with the IL-23p19 monoclonal antibody class. Between weeks 16 and 28, upper respiratory tract infections were the only treatment-emergent adverse event affecting more than 5% of patients.
Investigators reported two serious adverse events, a tibial fracture and a prostate cancer diagnosis in a patient with elevated baseline risk factors, and deemed neither related to the study drug. The trial recorded zero injection site reactions and no negative impacts from anti-drug antibodies.
Durability and Maintenance Dosing Still to Be Read Out
The EVERLAST-A study will continue through 52 weeks to evaluate response durability, maintenance dosing and long-term safety. Oruka Therapeutics (搜索) plans to release comprehensive long-term data for all patients in December 2026.
The company is also advancing the EVERLAST-B Phase 2b trial of ORKA-001, with new data from that study anticipated during the fourth quarter of 2026.