The clinical results highlight a clear dose-response relationship, with 61% of patients receiving a 600-milligram dose achieving complete skin clearance by week 16. In contrast, none of the participants in the placebo group reached this primary endpoint. Beyond the clearance rates, the company reported that the drug remains well tolerated by patients.

Chief medical officer Joana Goncalves noted that the trial data reinforces the potential for ORKA-001 to become a preferred treatment option due to its safety profile and infrequent dosing schedule of once or twice per year. Backed by these findings, Oruka is preparing to engage with regulatory agencies to finalize plans for Phase 3 trials, which are slated to begin in the first half of 2025.