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Jump to Key Points Nearly two thirds of adults with moderate-to-severe plaque psoriasis met the primary endpoint of a Psoriasis Area Severity Index (PASI) score of 100 at 28 weeks, after receiving treatment with a new monoclonal antibody, according to a press release from Oruka Therapeutics, developer of the medication.
EVERLAST-A, an ongoing randomized, double-blind, placebo-controlled phase 2a study, is evaluating the safety, efficacy, and pharmacokinetics of ORKA-001, an interleukin (IL)-23p19 monoclonal antibody with an extended half-life, in adults with moderate-to-severe plaque psoriasis.
In the study, which involves 26 sites in the US and Canada, patients were randomly assigned in a 3:1 ratio to a subcutaneous injection of 600 mg of ORKA-001 at weeks 0 and 4 or to placebo. Those in the placebo group crossed over to treatment and received ORKA-001 at weeks 16 and 20. Baseline characteristics were similar across the groups.
In previously reported interim data from 16 weeks, 40 of 63 participants (63.5%) who received ORKA-001 achieved complete skin clearance (PASI 100). In addition, 83% of patients who received ORKA-001 achieved PASI 90 and 84% achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 at 16 weeks, both secondary endpoints.
- ORKA-001 phase 2a: PASI 100 in 71.4% at 28 weeks.
- PASI 90 reached 87.3%; IGA 0/1 stable at 84.1%.
- Placebo crossover: 40% PASI 100 at 12 weeks post-dose.
- TEAEs similar vs placebo; URTI most common, 8% weeks 16–28.
- No serious TEAEs, injection-site reactions, or ADA PK impact reported.
In the update, the company reported that responses continued to improve through week 28, 6 months after the last dose was administered: At 28 weeks, 45 of 63 patients (71.4%) had achieved a PASI 100 response, and 55 of 63 (87.3%) had achieved a PASI 90 response. At 28 weeks, IGA 0 or 1 response rates remained stable from week 16, at 84.1%.
As for those who were in the placebo group and received treatment at week 16, 8 of 20 (40%) achieved PASI 100 at 28 weeks, 12 weeks after dosing, compared with 42.9% of those in the active arm at that timepoint, according to the company.
The overall rate of treatment-emergent adverse events (TEAEs) was similar across groups. At week 16, 51% and 57% of patients on treatment and placebo, respectively, reported at least one TEAE. Upper respiratory tract infections remained the most common TEAE at week 28, reported in 8% of the total study population between weeks 16 and 28. No serious TEAEs were reported in the treatment groups.
To date, no impact of antidrug antibodies on pharmacokinetics has been observed in the phase 1 or EVERLAST-A studies, and no injection site reactions have been reported, according to the company.
Looking ahead, 52-week results from EVERLAST-A are expected in December 2026, and 16-week data from the phase 2b EVERLAST-B study are expected in the fourth quarter of 2026, according to the company.
