Regeneron - Sanofi's Dupixent Improves Itch, Hives In Inflammatory Skin Disease Patients

Sanofi SA SNY and Regeneron Pharmaceuticals Inc's REGN have announced topline results from Phase 3 trial evaluating Dupixent (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU), an inflammatory skin disease.

• The 138-subject study met its primary endpoints and all key secondary endpoints at 24 weeks. 
• Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naïve patients, compared to those treated with antihistamines alone (placebo).
• Sanofi and Regeneron are jointly developing Dupilumab under a global collaboration agreement.
• Data demonstrated a 63% reduction in itch severity with Dupixent vs. 35% with standard-of-care. 65% reduction in urticaria activity (itch and hives) severity with Dupixent vs. 37% with standard-of-care was observed.
• For the 24-week treatment period, the occurrence of treatment-emergent adverse events was generally similar between the Dupixent and placebo groups (50% of Dupixent patients and 59% of placebo patients). 
• The most common adverse events were injection site reactions (11% Dupixent, 13% placebo).
• Another trial will evaluate Dupixent in adults and adolescents who remain symptomatic despite standard-of-care treatment and are intolerant or incomplete responders to an anti-IgE therapeutic (omalizumab). 
• Data readout from the study is in H1 of 2022. Sanofi and Regeneron plan to begin submissions in 2022. In addition to CSU, Dupixent is being evaluated in chronic inducible urticaria triggered by cold in an ongoing Phase 3 trial.
• Price Action: SNY shares are trading higher by 0.73% at $52.44, while REGN stock closed at $586.41 on Wednesday.