Oruka Therapeutics disclosed interim results from the EVERLAST-B Phase 2b trial for its experimental psoriasis drug ORKA-001. The company reported that 61% of patients in the 600 mg dose group achieved PASI 100, a measure of complete skin clearance, at Week 16. An additional 86% of patients in the same group reached PASI 90, indicating near-complete clearance. These figures align with data from the earlier EVERLAST-A trial, according to the company.
The presentation, dated October 26, 2026, was provided by Oruka Therapeutics as part of a Regulation FD disclosure. The company described the results as confirming the "remarkable profile" of ORKA-001. It noted that the efficacy levels were consistent with previous findings and highlighted a favorable safety profile similar to placebo. Oruka stated that it has accumulated more than 100 patient-years of experience with the drug, with safety data consistent with the IL-23 class of medications.
EVERLAST-B is a global Phase 2b trial conducted across sites in North America and Europe. The study included adults with moderate-to-severe chronic plaque psoriasis who had not previously been treated with anti-IL-23p19 therapies. The trial design aimed to determine the appropriate dose for future Phase 3 trials. Patients were randomized into four groups: a high-dose group receiving 600 mg, a mid-dose group receiving 300 mg, a low-dose group receiving 37.5 mg, and a placebo group. The primary endpoint was PASI 100 at Week 16.
The trial structure included an induction period followed by a maintenance phase. Patients who did not achieve complete clearance by Week 28 were not randomized further and instead received the high-dose ORKA-001 treatment every six months. The annual dosing strategy, involving a 600 mg dose at Week 52, was part of an open-label extension. Oruka indicated that this design supports the planned selection of a Phase 3 dose.
Oruka Therapeutics is a clinical-stage biopharmaceutical company with no approved products. Its pipeline includes two co-lead programs: ORKA-001, an ultra-long-acting IL-17A/F monoclonal antibody, and ORKA-002, an ultra-long-acting IL-23p19 monoclonal antibody. The company stated that these programs aim to set a new standard in psoriasis treatment, with potential for dosing intervals as long as every six months for psoriasis and psoriatic arthritis, and every three months for hidradenitis suppurativa.
The company expects to initiate Phase 3 trials in the first half of 2027. It also plans to release 52-week data from the EVERLAST-A trial in December to support the potential for annual dosing. Lawrence Klein, Chief Executive Officer, and Joana Goncalves, Chief Medical Officer, presented the findings. The presentation included disclaimers regarding forward-looking statements and noted that cross-trial comparisons are illustrative only, as no head-to-head trials have been conducted.