Frequently Asked Questions:
- What is ORKA-001?
ORKA-001 is an investigational monoclonal antibody against IL-23p19. It is engineered for an extended half-life, with the goal of maintaining psoriasis control on 1 or 2 doses per year.
- What did the EVERLAST-B trial show?
At week 16, 61% of patients receiving 600 mg ORKA-001 achieved PASI 100, vs 0% with placebo, and 86% reached PASI 90 and IGA 0/1.
- When will ORKA-001 enter phase 3?
Oruka plans to start phase 3 trials of the 600 mg dose in the first half of 2027, pending discussions with regulators.
ORKA-001, an investigational half-life extended interleukin (IL)-23p19 monoclonal antibody, produced complete skin clearance in 61% of high-dose recipients with moderate-to-severe plaque psoriasis at week 16 of the phase 2b EVERLAST-B trial, Oruka Therapeutics announced on October 26, 2026.¹
The readout builds on the phase 2a EVERLAST-A trial, in which 63.5% (40/63) of patients given 600 mg ORKA-001 reached PASI 100 at week 16, vs 1 of 21 placebo recipients.² Oruka is developing the antibody with the goal of sustaining disease control on a schedule as infrequent as 1 or 2 doses per year.¹
Joel Gelfand, MD, MSCE, lead investigator for EVERLAST-B and James J. Leyden Professor of Dermatology and Epidemiology at the University of Pennsylvania, said the data suggest ORKA-001 could be the most effective IL-23 targeted biologic studied to date. He noted nearly all of those involved in the trial could anticipate a strong response, with most seeing fully clear skin within 16 weeks.¹
How Did ORKA-001 Perform in the Phase 2b EVERLAST-B Trial?
EVERLAST-B is a randomized, double-blind, placebo-controlled study enrolling 187 adults at 36 sites in the US, Canada and Europe, fewer than 30% of which also took part in EVERLAST-A.¹ Participants were assigned 1:1:1:1 to placebo or 1 of 3 ORKA-001 regimens: 37.5 mg at week 0, 300 mg at weeks 0 and 4, or 600 mg at weeks 0 and 4.¹ PASI 100 at week 16 served as the primary end point.
Responses rose with dose. In the 600 mg group (n = 46), 61% of patients achieved PASI 100, compared with 0% of placebo recipients (n = 47; P < .0001).¹ Rates in the 300 mg and 37.5 mg groups reached 44% and 43%, respectively.¹
Among high-dose recipients, 86% achieved both PASI 90 and an Investigator’s Global Assessment (IGA) score of 0/1.¹ The mid-dose group posted 85% on each measure, while the low-dose group reached 70% for PASI 90 and 74% for IGA 0/1; no placebo recipient met either threshold.¹ According to Oruka, these results closely track those from EVERLAST-A.¹
What Is the Safety Profile of ORKA-001 in Plaque Psoriasis?
Through week 16, 49% (68/140) of all ORKA-001 recipients and 43% (20/47) of placebo recipients experienced at least 1 treatment-emergent adverse event (TEAE).¹ The rate in the high-dose group was 39% (18/46). Upper respiratory tract infection (14% [20/140]) and headache (6% [8/140]) were the only TEAEs reported in 5% or more of treated patients, occurring at frequencies Oruka described as comparable to approved IL-23 inhibitors.¹
