Cue Biopharma’s CUE-221 shows promising Phase 2 results against chronic hives

Cue Biopharma reported positive topline Phase 2 results for CUE-221 (UB-221), an experimental anti-IgE treatment for moderate-to-severe chronic spontaneous urticaria, or chronic hives.

In the 145-patient Chinese trial, complete hive resolution at Week 12 occurred in 54% of patients receiving 4 mg/kg, 53% receiving 2 mg/kg, and 43% receiving 1 mg/kg, versus 11% on placebo and 41% on Xolair (omalizumab).

A key secondary measure—complete response on the UAS7 scale—was achieved by 46% of patients on the 4 mg/kg dose, compared with 11% on placebo and 29% on Xolair.

Responses continued to improve after Week 12, peaking around Week 22. At Week 28—12 weeks after the final dose—60% of patients in the 4 mg/kg group had complete hive resolution versus 24% in the Xolair group.

Cue said the drug had a favorable safety profile, with no treatment-related serious adverse events or anaphylaxis reported in the topline data.

The company plans to advance CUE-221 into a Phase 2b/3 registration-enabling study. However, the apparent advantage over Xolair is based on topline and partly post hoc comparisons; larger confirmatory trials are needed to establish superiority.