Cue Biopharma reports Phase 2 CSU trial meets primary endpoint for anti-IgE drug CUE-221
CUE•Next development plans
Management plans rapid initiation of a Phase 2b/3 registration-enabling study in urticaria, while advancing a separate Phase 2 program in food allergy.
Differentiation versus Xolair and durability
Efficacy appeared differentiated versus Xolair, with benefits that persisted beyond the dosing period in the highest-dose group.
Complete results, including pharmacokinetic and IgE analyses, will be presented at a future scientific meeting.
Phase 2 chronic spontaneous urticaria results
Cue Biopharma reported positive topline Phase 2 results for CUE-221 in chronic spontaneous urticaria, supporting a move into Phase 2b/3.
The trial met its primary endpoint, showing clear symptom resolution benefits versus placebo with a generally favorable safety profile.
