Regeneron-Sanofi's Dupixent Hits Primary Goal In Esophagitis Patients Below 11 Years

• Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi SA's  (NASDAQ: SNY) Phase 3 trial of Dupixent (dupilumab) in children aged 1 to 11 years with eosinophilic esophagitis (EoE) met its primary endpoint of histological disease remission at 16 weeks.

• EoE is a chronic inflammatory disease that damages the esophagus and prevents it from working correctly.

• 68% of children on a higher dose and 58% of patients on a lower dose of Dupixent achieved histological disease remission compared to 3% of children on placebo.

• Related: FDA Accepts Regeneron, Sanofi's Filing For Review In Skin Disease.

• Children receiving the higher dose of Dupixent experienced an 86% reduction in peak esophageal intraepithelial eosinophil count from baseline at week 16 compared to a 21% increase for placebo.

• 0.88 and 0.84 reductions from baseline in disease severity and extent, respectively, than a 0.02 and 0.05 increase for placebo.

• 3.5-point reduction in abnormal endoscopic findings from baseline compared to a 0.3-point increase for placebo.

• In May 2022, the FDA approved Dupixent 300 mg weekly for EoE patients aged 12 years and above.

• Price Action: SNY stock is down 2.01% at $48.81 during the premarket session on Thursday's last check. REGN shares closed at $602.02 on Wednesday.

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