Oruka Reports Positive Week 28 Results For ORKA-001 In Plaque Psoriasis; Stock Down
(RTTNews) – Oruka Therapeutics, Inc. (ORKA) announced positive Week 28 results from its ongoing Phase 2a EVERLAST-A trial evaluating ORKA-001 in patients with moderate-to-severe plaque psoriasis.
The company said clinical responses continued to improve months after the last dose of treatment, while maintaining a favorable safety profile.
Plaque psoriasis is a chronic inflammatory skin disease that causes red, scaly patches on the skin. While several treatment options are available, many patients require ongoing therapy to maintain disease control.
ORKA-001 is a half-life extended IL-23p19 monoclonal antibody designed to provide long-lasting disease control with infrequent dosing. In the EVERLAST-A study, patients received 600 mg doses at Week 0 and Week 4.
EVERLAST-A randomized, double-blind, placebo-controlled Phase 2a trial evaluating the safety, efficacy, and pharmacokinetics of ORKA-001 in patients with moderate-to-severe plaque psoriasis. The study enrolled 84 patients across sites in the United States and Canada.
According to the company, responses continued to deepen through Week 28 despite no additional dosing after Week 4. The percentage of patients achieving PASI 100, a measure of complete skin clearance, increased to 71.4% while PASI 90 response rates rose to 87.3%.
Patients who initially received placebo and later crossed over to ORKA-001 achieved PASI 100 and PASI 90 response rates similar to those observed among patients who received ORKA-001 from the start of the study.
Safety findings through Week 28 were consistent with previously reported results, and ORKA-001 maintained a favorable safety and tolerability profile, according to the company.
The EVERLAST-A trial will continue through Week 52 to evaluate the durability of response, maintenance dosing, and long-term safety. Oruka expects to report 52-week data from the study in December 2026. The company also expects to report 16-week data from its EVERLAST-B trial during the fourth quarter of 2026.
ORKA has traded between $14.89 and $115.52 over the past year. The stock closed Tuesday’s trading at $94.55, up 1.25%. In pre-market trading the stock is at $89.00, down 5.87%.
