Oruka Therapeutics Announces Positive Week 16 Results for ORKA-001 from the Ongoing EVERLAST-B Trial in Moderate-to-Severe Psoriasis
Globe Newswire•26/10/2026•07:00 ET
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Key Highlights
- ➤ORKA-001 high-dose group achieved 61% PASI 100 at Week 16 versus 0% placebo (p<0.0001)
- ➤ORKA-001 high-dose group achieved 86% PASI 90 at Week 16
- ➤High-dose ORKA-001 had 39% TEAEs versus 43% for placebo
- ➤Oruka plans ORKA-001 Phase 3 psoriasis trials in the first half of 2027
- ➤Oruka expects 52-week EVERLAST-A results in December 2026
Expert Statements
Joana Goncalves, Chief Medical Officer of Oruka
“We are incredibly pleased with the remarkable profile of ORKA-001 observed to date, with highly consistent results achieved across EVERLAST-B and EVERLAST-A. These results further solidify our confidence that ORKA-001 could become the preferred medicine for psoriasis, with high rates of complete skin clearance, a favorable safety profile, and potential for dosing once to twice per year”
Joel Gelfand, James J. Leyden Professor of Dermatology and Epidemiology at the University of Pennsylvania and lead investigator for EVERLAST-B
“These results suggest ORKA-001 is likely to be the most effective IL-23-targeting biologic to date. Virtually all patients could expect to have a very good response, and the majority could expect to achieve completely clear skin within just 16 weeks. The potential for these effects to be long lasting, with just one or two doses a year, would be a paradigm shift in moderate-to-severe psoriasis management, allowing for the trifecta of clear skin, convenience, and excellent safety that would further elevate the standard of care we can offer our patients.”
61% PASI 100 and 86% PASI 90 in the ORKA-001 high-dose (600 mg) group, highly similar to EVERLAST-A
Continued favorable safety and tolerability profile consistent with the IL-23p19 class
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