Oruka Therapeutics reports Phase 2a interim data showing high skin clearance rates and favorable safety for ORKA-001 in plaque psoriasis.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Oruka Therapeutics reported interim results from its Phase 2a EVERLAST-A trial (NCT07090330) evaluating ORKA-001, a long-acting IL-23p19 monoclonal antibody, in moderate-to-severe plaque psoriasis. The randomized, double-blind, placebo-controlled study enrolled 84 patients across 26 sites in the United States and Canada, with participants assigned in a 3:1 ratio to receive ORKA-001 (600 mg at Weeks 0 and 4) or placebo.
At Week 16, 63.5% of patients treated with ORKA-001 achieved PASI 100, indicating complete skin clearance, with identical rates observed for an Investigator’s Global Assessment (IGA) score of 0. PASI 90 and IGA 0/1 responses were achieved by 83% and 84% of treated patients, respectively. In the placebo group, one participant reached these endpoints, consistent with prior psoriasis trials.
ORKA-001 was generally well tolerated, with no serious treatment-emergent adverse events reported and one severe event occurring in the placebo arm. Adverse events were mostly mild and occurred at similar rates in both groups (51% with ORKA-001 vs. 57% with placebo). The most common event was upper respiratory tract infection, reported in 19% of treated patients and 14% of those receiving placebo, and no injection site reactions were observed.
Pharmacokinetic data from earlier studies indicate that a single 600 mg dose maintains drug levels above effective thresholds for up to one year, with sustained inhibition of IL-23 signaling and no observed impact of anti-drug antibodies.
Joana Goncalves, MBChB, Chief Medical Officer of Oruka stated that the interim results met the upper range of expectations in terms of efficacy, tolerability, and durability, and emphasized optimism about the therapy’s emerging profile and forthcoming long-term data.
Bruce Strober, MD PhD, Lead investigator for EVERLAST-A described the results as highly compelling, noting that if similar efficacy and safety are maintained with infrequent dosing, the therapy could represent a significant advancement and a potential preferred option for patients with moderate-to-severe psoriasis.
Oruka plans to report additional data, including Week 28 efficacy and 52-week follow-up results, in the second half of 2026, while a Phase 2b trial (EVERLAST-B) is ongoing with results expected in 2027.
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About the Writer
Nikita Jha, BPharm a pharmacy graduate specializing in medical writing, with a strong ability to interpret complex medical and regulatory information and translate it into clear, accurate, and evidence-based healthcare content. Known for her attention to detail and precision, she focuses on delivering high-quality scientific communication that supports drug safety and informed decision-making.