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

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

The China-based, randomized trial enrolled 145 patients whose symptoms were inadequately controlled by H1 antihistamines. It compared three CUE-221 doses with placebo and Xolair (omalizumab).

At week 12, complete resolution of hives occurred in 54% of patients receiving 4 mg/kg, 53% receiving 2 mg/kg, and 43% receiving 1 mg/kg, versus 11% on placebo. The 4 mg/kg result compared with 41% for Xolair.

A key secondary endpoint—complete disease response—was achieved by 46% of patients at the 4 mg/kg dose, versus 11% on placebo and 29% with Xolair.

Benefits appeared durable:
12 weeks after treatment ended, 60% of patients in the 4 mg/kg group remained hive-free, compared with 24% in the Xolair group. The company described this comparison as post hoc, so it requires confirmation in a larger trial.

Cue reported no treatment-related serious adverse events or cases of anaphylaxis in the study.

The company plans to advance CUE-221 into a Phase 2b/3 registration-enabling trial, subject to regulatory discussions, and is also considering development in food allergy.