Cue Biopharma announced positive topline results from a Phase 2 clinical trial of its drug candidate, CUE-221, for the treatment of Chronic Spontaneous Urticaria (CSU). The trial, which enrolled 145 participants, successfully met its primary and key secondary endpoints, demonstrating a statistically significant and dose-responsive reduction in hive severity compared to placebo. Based on these findings, the company plans to advance CUE-221 into a Phase 2b/3 registration-enabling trial for CSU.
Key Details
- Primary Endpoint Met: At Week 12, the 4 mg/kg dose of CUE-221 achieved a 54% complete hive resolution rate (HSS7=0), compared to 11% for placebo (p < 0.005). All CUE-221 dose levels met the primary endpoint with statistical significance.
- Durable Response: The treatment effect persisted after dosing ended. At Week 28 (12 weeks off-drug), 60% of patients in the 4 mg/kg group maintained complete hive resolution, a statistically significant difference compared to the 24% for the active comparator, omalizumab.
- Favorable Safety Profile: CUE-221 was well-tolerated across all dose groups, with no treatment-related serious adverse events or cases of anaphylaxis reported.
- Future Development: The company intends to initiate a Phase 2b/3 trial in CSU and a Phase 2 trial of CUE-221 in food allergy, pending FDA review.