ORKA-002 for psoriasis phase 1 started

[Fred]

Update:

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• PK: ORKA-002 showed a half-life of 75-80 days, greater than three times that of bimekizumab, and a comparable Cmax to bimekizumab at equivalent doses based on previously reported bimekizumab data. Pharmacokinetic modeling based on these results supports achieving twice-yearly maintenance dosing in PsO and quarterly maintenance dosing in HS.
  
• Pharmacodynamics (PD): In an ex vivo IL-17 stimulation assay, ORKA-002 was shown to potently inhibit IL-17 signaling at all dose levels through last follow-up (up to 24 weeks), further supporting the potential for twice-yearly dosing.
  
• Safety: ORKA-002 was well tolerated at all dose levels, with a favorable safety profile consistent with the anti-IL-17 class. There were no severe treatment-emergent adverse events (TEAEs) or serious adverse events, and no discontinuations. The only TEAEs to occur in more than two subjects were contusion, headache, skin abrasion and upper respiratory tract infection. The study remains blinded, and all subjects remain on study.
  

ORKA-002: Phase 2 Trials in Plaque Psoriasis

• ORCA-SURGE, a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 trial designed to evaluate the safety and efficacy of ORKA-002 in moderate-to-severe PsO patients, is expected to commence in the first half of 2026. ORCA-SURGE is designed to enroll approximately 160 patients randomized 1:1:1:1 to receive 40 mg, 160 mg or 320 mg of ORKA-002 at Weeks 0 and 4, or matching placebo. The primary endpoint will be PASI 100 at Week 16. Maintenance dosing will evaluate the potential for twice-yearly dosing with ORKA-002. Data from ORCA-SURGE is anticipated in 2027.
  

Source: orukatx.com