Oruka Therapeutics Inc. (NASDAQ:ORKA) on Monday reported positive Week 16 results from its EVERLAST-B Phase 2b clinical trial evaluating ORKA-001 in patients with moderate-to-severe plaque psoriasis.
Strong Efficacy Across Dose Groups
The investigational biologic, an extended half-life IL-23p19 monoclonal antibody, met its primary efficacy endpoint by achieving significant skin clearance compared to placebo.
The study enrolled 187 participants. Investigators assigned participants across four cohorts: a 37.5 mg single dose, a 300 mg regimen at Weeks 0 and 4, a 600 mg regimen at Weeks 0 and 4, or a matching placebo.
Patients receiving the 600 mg high dose demonstrated superior results, clearing skin in a dose-dependent fashion.
At Week 16, 61% of high-dose patients attained complete clearance with a PASI 100 response, compared to 0% in the placebo group.
In addition, 86% of high-dose participants reached PASI 90 and an Investigator’s Global Assessment score of 0 or 1, matching outcomes from the earlier EVERLAST-A study.
Class-Consistent Safety Profile
ORKA-001 remained well tolerated throughout the 16 weeks, aligning with the established safety profile of the IL-23p19 class.
Overall, 39% of patients in the high-dose cohort experienced treatment-emergent adverse events, compared to 43% of participants receiving placebo.
Regulatory Discussions And Next Milestones
Following these clinical outcomes, Oruka intends to discuss Phase 3 trial plans with regulatory authorities.
The biotechnology company plans to initiate Phase 3 trials in moderate-to-severe plaque psoriasis in the first half of 2027 using the 600 mg high dose.
The company also anticipates reporting 52-week data from EVERLAST-A in December 2026, followed by 52-week results from EVERLAST-B in the second half of 2027.
ORKA Price Action: Oruka Therapeutics shares were up 16.07% at $93.03 at the time of publication on Monday, according to Benzinga Pro data.
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