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Oruka Therapeutics Announces Positive Interim Phase 1 Data for ORKA-002 and Initiation of EVERLAST-B Trial of ORKA-001
ORKA-002 interim Phase 1 data demonstrates a half-life of 75-80 days supporting potential for twice-per-year dosing in psoriasis and quarterly dosing in
About this update from Oruka Therapeutics, Inc.
[{"type":"text","content":"ORKA-002 interim Phase 1 data demonstrates a half-life of 75-80 days supporting potential for twice-per-year dosing in psoriasis and quarterly dosing in hidradenitis suppurativa Phase 2 studies for ORKA-002 expected to begin in 1H 2026 for psoriasis and 2H 2026 for hidradenitis suppurativa First patients dosed in EVERLAST-B Phase 2b trial of ORKA-001 in December 2025 with data expected in 2027 MENLO PARK, Calif., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today announced positive interim data from its Phase 1 trial of ORKA-002 and updates from the ongoing trials of ORKA-001. “We’re thrilled with the rapid progress we are making with both ORKA-001 and ORKA-002 and their emerging potentially best-in-class product profiles,” said Lawrence Klein, PhD, CEO. “We continue to build conviction that each of these assets could play a very important role in the future treatment of psoriatic disease and beyond. This Phase 1 data for ORKA-002 increases our confidence in its potential differentiation in both psoriasis and hidradenitis suppurativa (HS), and we’re highly encouraged by how quickly our EVERLAST trials are progressing and the enthusiasm we are seeing for ORKA-001’s paradigm-changing potential.” ORKA-002: Key Phase 1 Interim Findings The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and pharmacokinetics (PK) of ORKA-002 in healthy volunteers. The study enrolled 24 healthy adult participants into three single-ascending subcutaneous dose cohorts of 160 mg, 320 mg and 640 mg. Interim results from the trial as of the January 2026 data cutoff are as follows, and additional data will be presented at an upcoming medical meeting. 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 i...