ORKA-001 Phase 1 Data Support Potential Once-Yearly IL-23 Dosing

A half-life–extended IL-23p19 monoclonal antibody demonstrated sustained pharmacokinetics and favorable tolerability that may support once-yearly dosing in plaque psoriasis, according to “Phase 1 Clinical Data of ORKA-001, a Novel Half-Life–Extended IL-23p19 Monoclonal Antibody,” a poster by James Krueger, MD, PhD, et al presented as part of the “Best of the Best at Maui Derm” late breakers session at at Maui Derm Hawaii 2026.

In healthy volunteers, ORKA-001 exhibited an estimated ~100-day half-life, sustained pharmacodynamic suppression of IL-17 signaling, and no serious adverse events across dose levels.

“These Phase 1 data support the potential for extended dosing intervals while maintaining therapeutic antibody exposure,” the authors reported.

ORKA-001 is currently being evaluated in an ongoing Phase 2a study in patients with moderate-to-severe psoriasis.

“What’s exciting here is the Fc modification,” said Jason E. Hawkes, MD. “By preventing degradation and recycling the antibody, you maintain higher exposure for longer periods, which could translate into once-yearly dosing.”

Linda Stein Gold, MD, added, “With a half-life of about 100 days and a safety profile that looks clean so far, this could be a major advance in patient convenience if efficacy holds up in later-phase studies.”