Oruka Therapeutics received FDA clearance for its Investigational New Drug (IND) application to begin the Phase 2a clinical trial, EVERLAST-A, of ORKA-001 for moderate-to-severe psoriasis. The trial will assess the safety and efficacy of a single dose of ORKA-001, a long-acting anti-IL-23p19 antibody, with initial data anticipated in the second half of 2026. Interim Phase 1 data and further EVERLAST-A study details will be presented at the European Academy of Dermatology and Venereology (EADV) Congress in September.
This IND clearance is a crucial step forward in the development of potentially superior treatments for psoriasis. The trial’s unique design, including a “no-dose” arm for patients achieving complete skin clearance (PASI 100), could demonstrate the potential for once-yearly dosing and extended off-treatment remission. This could significantly improve the quality of life for psoriasis patients, who currently require more frequent dosing with existing therapies. The possibility of achieving higher rates of PASI 100 compared to currently available IL-23p19 inhibitors could also reshape treatment paradigms.
EVERLAST-A, a randomized, double-blind, placebo-controlled trial, will enroll approximately 80 patients. The trial aims to achieve ORKA-001 exposures surpassing those in previous studies, directly testing the hypothesis that higher exposures correlate with increased efficacy. The primary endpoint is PASI 100 at Week 16. At Week 28, patients achieving PASI 100 will be further randomized to either receive no further treatment until disease recurrence or continue receiving ORKA-001 every six months. Patients not achieving PASI 100 by Week 28 will receive ORKA-001 every six months.
Positive results from the EVERLAST-A trial could establish ORKA-001 as a best-in-class treatment for psoriasis, offering patients a more convenient dosing regimen and potentially superior efficacy. This could lead to increased market share for Oruka and further validate the potential of long-acting biologics in treating chronic skin conditions. The data from this trial is highly anticipated and could significantly influence the future treatment landscape for psoriasis.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
