In the latest win for Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab), the partners announced positive results from a Phase III trial of the blockbuster in kids ages one to 11 years with eosinophilic esophagitis (EoE).
Dupixent has been approved globally for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) or EoE in other age groups. There are no approved treatments for EoE for children under the age of 12.
The study hit the primary endpoint of histological disease remission at 16 weeks with both higher and lower dose weight-tiered dosages. There was an 86% decrease in esophageal intraepithelial eosinophil count from baseline compared to a 21% increase for placebo. The study demonstrated a 3.5-point decrease in abnormal endoscopic findings from baseline compared to the placebo level of 0.3 points. There was also a numerical improvement in the proportion of days the kids had experienced symptoms of EoE from baseline as reported by caregivers, although it was not classified as statistically significant.
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