Oruka Therapeutics has reported positive interim data from the ongoing EVERLAST-A Phase IIa trial evaluating ORKA-001 in patients with moderate-to-severe plaque psoriasis.
The randomised, double-blind, placebo-controlled trial of the half-life extended IL-23p19 monoclonal antibody is being conducted at 26 sites across Canada and the US.
A total of 84 patients were randomised into a 3:1 ratio to receive either 600mg of ORKA-001 or a matching placebo at weeks zero and four.
Baseline patient characteristics matched recent studies in the same indication.
At week 16, 40 of 63 participants (63.5%) who received ORKA-001 achieved psoriasis area and severity index 100 (PASI 100), the trial’s primary endpoint, corresponding to complete skin clearance.
The same result was observed for investigator’s global assessment 0 (IGA 0).
Secondary endpoints included PASI 90 achieved by 83% of participants and IGA 0/1 by 84% of ORKA-001 recipients. Among 21 placebo recipients, one achieved these endpoints. All response rates used non-responder imputation for analysis.
Safety findings indicated ORKA-001 was well tolerated, with no serious treatment-emergent adverse events and a TEAE rate similar to placebo.
Upper respiratory tract infection was reported in 19% of the ORKA-001 group and 14% in placebo. No injection site reactions were observed.
Pharmacokinetic and pharmacodynamic data from previous trials continue to support the potential for annual dosing, with sustained drug levels and IL-23 pathway inhibition for one year post-dose.
The company aims to announce longer-term EVERLAST-A data in late 2026 and will continue advancing the parallel Phase IIb EVERLAST-B trial, with results expected in 2027.
Oruka Therapeutics chief medical officer Joana Goncalves said: “These data reached the top end of what we could have expected from ORKA-001 across efficacy, tolerability, and potential for long-lasting response.
“We’re thrilled with the profile that is emerging for this programme and are excited to see how the data matures with longer-term follow-up. I want to thank the Oruka team, the EVERLAST-A investigators, and the trial participants for getting this study off to a tremendous start.”
