Cue Biopharma said its Phase 2 trial in China found complete resolution of chronic hives at week 12 in 54% of patients given CUE-221 at 4 mg/kg, versus 11% on placebo. The 145-patient study met its primary endpoint; its week-28 omalizumab comparison was post hoc.
At week 28—12 weeks after the final dose—60% of the highest-dose group had complete hive resolution, versus 24% of the omalizumab group. The 36-percentage-point difference came from a post hoc analysis, not a planned statistical comparison. Both groups had stopped treatment, so the finding does not establish an advantage over continued omalizumab dosing.
At week 12, 46% in the highest-dose group had no hives or itching on the weekly urticaria activity score, versus 11% on placebo; this secondary endpoint was significant at p<0.05. Cue reported no treatment-related serious adverse events or hypersensitivity reactions, including anaphylaxis, and plans a Phase 2b/3 study intended to support registration.
