Sixty-one percent of patients given a single 600 mg dose of ORKA-001 achieved complete skin clearance at 16 weeks, with zero placebo patients reaching the same mark, p<0.0001. That primary endpoint result from Oruka Therapeutics’ Phase 2b EVERLAST-B trial matters because the 600 mg regimen is dosed only at Weeks 0 and 4, and Oruka’s Phase 3 design targets once-yearly maintenance from Week 52 onward. The dosing interval, not just the clearance rate, is the clinical argument the company is building.

The 187-patient trial tested three dose levels against placebo. At the high dose, 86% of patients reached PASI 90 and 86% met IGA 0/1 by Week 16, while the adverse event profile was notably quiet: only 39% of the 600 mg group reported any treatment-emergent adverse event, below the 43% rate in the placebo arm. No serious adverse events occurred in that group, and no injection site reactions were reported across any ORKA-001 arm. The high-dose results were broadly consistent with what Oruka saw in EVERLAST-A, where results in the 600 mg group were broadly consistent with EVERLAST-A findings at the same timepoint. The two trials are now telling a consistent efficacy story heading into Phase 3.

Oruka is entering a category that already includes approved IL-23p19 inhibitors: guselkumab, dosed every eight weeks after an initial loading period, and risankizumab, dosed every 12 weeks for maintenance. ORKA-001’s half-life extension is designed to push that interval to once yearly, which would mean fewer patient visits and a structurally different payer conversation. Whether the efficacy data at Week 16 translates into durable remission at 52 weeks is the unresolved question, and the answer comes in December when EVERLAST-A’s one-year readout is expected.

Phase 3 initiation is planned for the first half of 2027, subject to regulatory interactions on the 600 mg dose. With $1.1 billion in cash as of June 30, 2026, Oruka says it has enough runway to reach a BLA filing. The 52-week EVERLAST-A data in December will be the first real test of whether the once-yearly maintenance premise holds under sustained follow-up.

Source link: https://www.sec.gov/Archives/edgar/data/907654/000121390026112281/ea0309594-8k_oruka.htm

ORKA-001: the facts in one place

  • Also written: ORKA 001, ORKA-021, PR-035
  • Sponsor: Oruka Therapeutics, Inc.
  • Mechanism: IL-23p19 monoclonal antibody, half-life-extended
  • Indication studied: moderate-to-severe plaque psoriasis; potential implications for generalized pustular psoriasis
  • Phase: Phase 2 (Phase 3 anticipated first half of 2027)
  • Enrollment: EVERLAST-A: 84 patients; EVERLAST-B: 187 patients; open-label extension: 240 participants
  • Primary endpoint: proportion of patients achieving PASI 100 at Week 16 (EVERLAST-B)
  • Headline result: single 600 mg dose of ORKA-001 achieved PASI 100 in 61% of patients vs 0% placebo at Week 16 in EVERLAST-B
  • Registry identifier: NCT07090330, NCT07290569, NCT07449702
  • Current status: Phase 2 complete for Week 16; Phase 3 discussions with regulatory authorities planned; Phase 3 initiation anticipated first half of 2027
  • EVERLAST-A Week 16 data announced: April 27, 2026
  • EVERLAST-B Week 16 data announced: October 26, 2026
  • EVERLAST-A 52-week data expected: December 2026
  • EVERLAST-B 52-week data expected: second half of 2027
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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.