MENLO PARK, Calif. — September 23, 2026

Oruka Therapeutics announced positive Week 28 data from the ongoing EVERLAST-A Phase 2a trial of ORKA-001 in patients with moderate-to-severe plaque psoriasis. Clinical responses continued to deepen despite no ORKA-001 dosing after Week 4, with PASI 100 response rates increasing to 71.4% and PASI 90 response rates reaching 87.3% at Week 28. Oruka also reported that ORKA-001 maintained a favorable safety and tolerability profile through Week 28, with 52-week EVERLAST-A data expected in December 2026.

ORKA-001 Responses Deepen After Last Dose

Among patients initially treated with ORKA-001, PASI 100 responses increased from 63.5% at Week 16 to 71.4% at Week 28, representing 45 of 63 patients achieving complete skin clearance. PASI 90 responses increased to 87.3%, or 55 of 63 patients, while IGA 0/1 responses were maintained at 84.1%. The continued improvement occurred approximately six months after the last ORKA-001 dose, providing an early assessment of response durability. The findings remain from an ongoing Phase 2a study, and longer-term data are still needed to characterize durability and dosing requirements.

Placebo Crossover Patients Show Clinical Responses

Patients who initially received placebo and subsequently crossed over to ORKA-001 also demonstrated clinical responses after treatment. In the crossover group, 40.0% of patients achieved PASI 100 at Week 28, 12 weeks after receiving ORKA-001, compared with 42.9% of patients in the initially treated group at the equivalent timepoint. EVERLAST-A is a randomized, double-blind, placebo-controlled study involving 84 patients across 26 sites in the United States and Canada. The trial evaluates two 600 mg doses of ORKA-001 administered at Weeks 0 and 4, with the study continuing through Week 52 to assess efficacy durability, maintenance dosing and long-term safety.

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Oruka Advances ORKA-001 Toward Longer-Term Data

ORKA-001 maintained a safety profile consistent with the IL-23p19 monoclonal antibody class through Week 28, according to the company. Between Weeks 16 and 28, upper respiratory tract infection was the only treatment-emergent adverse event occurring in at least 5% of ORKA-001-treated patients, reported in 8% of patients. Two serious adverse events were reported during the period, involving a tibial fracture and prostate adenocarcinoma, and neither was considered related to treatment. Oruka reported no injection-site reactions and no observed impact of anti-drug antibodies on safety, efficacy or pharmacokinetics. The company expects to report 52-week EVERLAST-A data in December 2026, while 16-week data from the EVERLAST-B Phase 2b trial are expected in the fourth quarter of 2026.

Source :Oruka Therapeutics, press release