Dupixent shows improved esophageal function in phase 4 trial for EoE

Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) and Sanofi presented results from a Phase 4 trial showing Dupixent demonstrated statistically significant improvements in esophageal function and disease-related structural changes in adults with eosinophilic esophagitis (EoE) compared to placebo at 24 weeks.

The REMODEL trial enrolled 69 adults with EoE who received either Dupixent 300 mg weekly (46 patients) or placebo (23 patients). Results showed Dupixent improved esophageal distensibility by 1.28 mm from baseline versus -0.01 mm for placebo, representing a 9% improvement compared to 1% for placebo.

The drug also demonstrated a 4.89-point reduction in abnormal endoscopic findings as measured by the EREFS scale, compared to a 0.07-point increase with placebo. Additionally, 59% of Dupixent patients achieved histological remission with eosinophil counts of ≤6 per high-power field, compared to 4% of placebo patients.

"Dupixent showed a potential to modify the course of eosinophilic esophagitis – by improving esophageal size at just 6 months," said lead study author Evan Dellon from the University of North Carolina School of Medicine. The magnitude of improvement corresponded to benefits seen from esophageal dilation procedures, according to the researcher.

Safety results were generally consistent with Dupixent's known profile in EoE. Adverse events occurred in 62% of Dupixent patients versus 48% on placebo, with injection site pain and headache being more common with the drug. No serious adverse events were reported in either group.

EoE is a chronic inflammatory disease that causes scarring and narrowing of the esophagus, making swallowing difficult. Dupixent was the first biologic approved for this condition and remains the only one indicated for EoE treatment.

The information is based on a press release from Regeneron and Sanofi presented at the 2026 Digestive Disease Week conference.

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