ORKA-002 for psoriasis phase 1 started

[Fred]

ORKA-002 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A/F that has the potential to be dosed just two to three times per year in psoriasis (PsO) and psoriatic arthritis (PsA)

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Oruka Therapeutics, a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced that it has initiated dosing of healthy volunteers in its first clinical trial of ORKA-002, the Company’s novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A and IL-17F (IL-17A/F).

“With both ORKA-001 and ORKA-002 now in human trials, we are moving quickly to demonstrate the clinical differentiation of both assets,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Bimekizumab is launching extremely well as IL-17A/F has emerged as superior to IL-17A inhibition in several important indications. Uniquely, we could have the best targeting approaches for both IL-23p19 and IL-17A/F, potentially allowing us to offer the ideal regimen to patients through our ORKA-001 and -002 monotherapies and our ORKA-021 sequential combination.”

The ORKA-002 Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of ORKA-002 in approximately 24 healthy volunteers across three subcutaneous dose cohorts. Oruka expects to share interim data from this study around year end 2025.

Pending data from the Phase 1 trial, Oruka plans to initiate a Phase 2 study of ORKA-002 in moderate-to-severe psoriasis in the first half of 2026. The planned study design will evaluate the safety and efficacy of multiple dose levels and regimens of ORKA-002, with a primary endpoint of PASI 100 at week 16.

“ORKA-002 has the opportunity to become the best antibody in the IL-17 class, which is preferred when treating psoriasis with joint involvement or recalcitrant skin disease, as well as psoriatic arthritis, hidradenitis suppurativa, and beyond,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “With this program now in the clinic, we are one step closer to our goal of offering the most possible freedom from disease to patients with psoriasis and other conditions.”

Source: orukatx.com

[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