Cue Biopharma reported positive topline results from a Phase 2 trial of CUE-221 for moderate to severe chronic spontaneous urticaria (CSU). The study involved 145 participants in China who previously showed an inadequate response to H1 antihistamines.
The trial met its primary and key secondary endpoints with statistical significance. The highest dose of CUE-221 achieved a 54% complete resolution of hives at week 12. This compared to an 11% resolution rate for the placebo group.
CUE-221 demonstrated effectiveness across multiple dose levels and maintained a favorable safety profile. No treatment-related serious adverse events occurred during the trial.
Cue Biopharma plans to advance the drug candidate into a late-stage Phase 2b/3 study based on these results.