Oruka Therapeutics Inc. (NASDAQ:ORKA) on Wednesday reported positive week 28 outcomes from its Phase 2a clinical trial evaluating ORKA-001 for moderate-to-severe plaque psoriasis.
The clinical-stage biotechnology firm noted that patient responses improved significantly six months after receiving their final dose of the novel antibody.
Phase 2a Trial Demonstrates Deepening Efficacy
Data showed that 63.5% of treated patients achieved complete skin clearance, or PASI 100, at week 16.
Clinical improvements continued to deepen by week 28. PASI 100 response rates increased to 71.4%, and PASI 90 response rates climbed to 87.3%.
The trial also maintained IGA 0/1 response rates at 84.1%.
Patients transitioning from the placebo group to receive the active drug at weeks 16 and 20 exhibited a similar pattern of improvement.
Twelve weeks after their initial dose, 40% of these crossover patients achieved PASI 100, aligning closely with the active arm at the equivalent timepoint.
Consistent Safety Profile And Tolerability
ORKA-001 remains well-tolerated, demonstrating a safety profile consistent with the IL-23p19 monoclonal antibody class.
Between weeks 16 and 28, upper respiratory tract infections represented 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—but deemed neither related to the study drug.
The trial recorded zero injection site reactions and no negative impacts from anti-drug antibodies.
Upcoming Milestones For Oruka Therapeutics
The EVERLAST-A study will continue through 52 weeks to evaluate response durability, maintenance dosing, and long-term safety. Oruka Therapeutics plans to release this comprehensive long-term data for all patients in December 2026.
Additionally, the biotechnology company continues advancing its EVERLAST-B Phase 2b trial for ORKA-001. Market observers anticipate new data from this subsequent trial during the fourth quarter of 2026.
ORKA Price Action: Oruka Therapeutics shares were down 0.30% at $94.26 at the time of publication on Wednesday, according to Benzinga Pro data.
Photo: lucadp / Shutterstock – ek