Oruka’s ORKA-001 Shows 100-Day Half-Life, Paving Way for Once-Yearly Psoriasis Treatment

Oruka’s ORKA-001 Shows 100-Day Half-Life, Paving Way for Once-Yearly Psoriasis Treatment

By, Admin 19 September 2025

Oruka Therapeutics has shared interim Phase 1 data for ORKA-001, a long-acting IL-23p19 antibody, at the EADV Congress in Paris. The candidate could reshape plaque psoriasis (PsO) care by enabling once-yearly dosing and higher skin clearance rates than current treatments.

Why This Matters

  • Psoriasis burden: Current IL-23p19 therapies are injected 4–6 times per year.
  • Clearance gap: Less than half of patients reach fully clear skin (PASI 100) at four months.
  • Big promise: ORKA-001 aims for annual dosing, higher efficacy, and even off-treatment remissions.

Key Phase 1 Findings

  • Pharmacokinetics: Half-life of ~100 days—over 3x longer than risankizumab.
  • Pharmacodynamics: Complete inhibition of STAT3 signaling for 24 weeks.
  • Safety: Favorable profile; most common issues were headache, mild infections, and transient injection-site reactions. No severe events reported.

EVERLAST-A: The Phase 2a Trial

  • Design: 80 patients, randomized 3:1 (ORKA-001 vs placebo).
  • Dose: 600 mg at Weeks 0 and 4.
  • Primary endpoint: PASI 100 at Week 16.
  • Durability test: Patients with full clearance at Week 28 will either stop dosing until relapse or shift to twice-yearly dosing.
  • Placebo arm: Switches to ORKA-001 at Week 16, then tested for yearly dosing.
  • Timeline: Initial readout expected 2H 2026.

Next Steps

  • EVERLAST-B (Phase 2b): Starts 1H 2026. Will test three dosing regimens:
    - 37.5 mg at Week 0
    - 300 mg at Weeks 0 + 4
    - 600 mg at Weeks 0 + 4
  • Primary endpoint: PASI 100 at Week 16.

The Bigger Picture

  • ORKA-001 could extend dosing intervals from every 2–3 months to just once per year.
  • Higher exposures than marketed IL-23p19s may unlock best-in-class clearance rates.
  • Oruka’s mission: give patients freedom from chronic skin disease with long-lasting, simplified therapy.

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