Oruka Therapeutics drug cleared skin in 64% of psoriasis patients in trial

ORKA-001 also met secondary endpoints at 16 weeks, and updated data support the potential for once-yearly dosing

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Oruka Therapeutics reported Monday that 63.5% of patients treated with its experimental psoriasis drug, ORKA-001, achieved complete skin clearance at 16 weeks in an ongoing Phase 2a clinical trial.

At week 16, complete skin clearance — defined as a PASI 100 score — was achieved by 40 of the 63 ORKA-001-treated participants in EVERLAST-A, Oruka said. One of 21 participants in the placebo group reached the same endpoint. Secondary endpoints were also met: 83% of treated participants achieved PASI 90, and 84% reached IGA 0/1, a measure of overall skin improvement, Oruka said.

ORKA-001 is a long-acting IL-23p19 monoclonal antibody being studied in people with moderate-to-severe plaque psoriasis. Oruka said there were no serious side effects linked to the drug and no one stopped treatment because of it. The overall safety profile was similar to placebo. The most common side effect was upper respiratory tract infection, seen in 19% of treated patients and 14% of those on placebo. No injection site reactions were reported.

Separately, Oruka released updated Phase 1 data showing that a single 600 mg dose kept circulating drug levels above therapeutically relevant thresholds for twelve months. The company said the data support the potential for once-yearly dosing.

"These data reached the top end of what we could have expected from ORKA-001 across efficacy, tolerability, and potential for long-lasting response," Chief Medical Officer Joana Goncalves said in a statement.

Oruka plans to release additional data from EVERLAST-A — including efficacy results at week 28 for all patients and 52-week follow-up data for a subset — in the second half of 2026. A separate Phase 2b dose-ranging trial, EVERLAST-B, is enrolling about 160 patients, with results expected in 2027, according to TipRanks.

The Menlo Park, California-based company said cross-trial comparisons showed ORKA-001 produced numerically higher skin-clearance rates than other drugs in the IL-23p19 inhibitor class. Oruka acknowledged the comparison is indirect and comes before late-stage trial data are available. Late-stage trials would still be required before the drug could seek regulatory approval.

Before any regulatory submission would be possible, the drug must still advance through late-stage trials, STAT News noted.

Oruka stock was up about 32% in premarket trading Monday following the announcement.

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