Core Insights - The U.S. FDA has cleared Oruka Therapeutics' IND application for the Phase 2a trial of ORKA-001 in moderate-to-severe psoriasis, named EVERLAST-A, with initial data expected in the second half of 2026 [1][2] - ORKA-001 is a long-acting anti-IL-23p19 antibody that aims to redefine the standard of care for psoriasis, potentially allowing for once-per-year dosing and higher rates of disease clearance [2][4] Company Overview - Oruka Therapeutics is focused on developing novel biologics to set a new standard for treating chronic skin diseases, particularly plaque psoriasis, with a mission to achieve high rates of complete disease clearance with infrequent dosing [5][6] - The company is advancing a proprietary portfolio of antibodies targeting the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases [5] Clinical Trial Details - The EVERLAST-A trial will enroll approximately 80 patients, randomized 3:1 to receive ORKA-001 or a matching placebo, with the primary endpoint being PASI 100 at Week 16 [2] - Patients achieving PASI 100 at Week 28 will be randomized to either a "no-dose" arm or receive ORKA-001 every six months, providing evidence for yearly dosing and potential extended off-treatment remissions [2] - Interim data from the Phase 1 study and further details on the EVERLAST-A design will be presented at the EADV Congress in September [1][2] Product Information - ORKA-001 is a subcutaneously administered monoclonal antibody with a significantly extended half-life, designed to achieve higher exposures than currently marketed IL-23p19 antibodies [4] - Current therapies for moderate-to-severe psoriasis require dosing four to six times per year, with less than half of patients achieving PASI 100 after four months, whereas ORKA-001 aims for dosing just once or twice a year [4]