Cue Biopharma: CUE-221 Phase 2 in CSU meets primary and key secondary endpoints

Cue Biopharma, Inc.

• Phase 2 trial (N=145) met primary endpoint HSS7=0 at week 12 at all doses: 54% (4mg/kg) vs 11% placebo, p<0.005.
• Key secondary endpoint UAS7=0 met at 4mg/kg: 46% vs 11% placebo, p<0.05; dose-responsive.
• Safety favorable: no treatment-related SAEs or anaphylaxis; only one >grade1 injection site reaction, none led to discontinuation.
• Plans to initiate Phase 2b/3 in CSU and Phase 2 in food allergy; IND for food allergy submitted to FDA.