Sanofi-Regeneron's Dupixent Falls Short In Chronic Spontaneous Urticaria Trial

Sanofi SA SNY and Regeneron Pharmaceuticals Inc REGN have reported disappointing results from the Phase 3 trial of Dupixent (dupilumab) in chronic spontaneous urticaria (CSU).

• The trial included CSU patients who don't respond to biologic treatment, Novartis AG NVS / Roche Holdings AG's RHHBY Xolair (omalizumab). 
• CSU is a severe form of hives, causing severe itching and swelling.
• In the study, dupilumab couldn't significantly improve symptoms in Xolair-refractory patients.
• The trial will be stopped for futility, although the antibody did show "numeric improvements" on itching and hive symptoms.
• Related: Sanofi - Regeneron's Dupixent Under FDA Priority Review For Children Under 5 Years With Atopic Dermatitis.
• The previously reported Phase 3 trial, which evaluated CSU patients who were biologic-naïve, met its primary and all key secondary endpoints at 24 weeks.
• Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives compared to antihistamines alone.
• The companies are evaluating the next steps.
• Price Action: SNY shares are trading higher by 0.49% at $53.13 during the premarket session on the last check Friday, while REGN stock closed at $626.72 on Thursday.