Dupixent shows esophageal function gains in Phase 4 EoE trial
Regeneron Pharmaceuticals and Sanofi have presented Phase 4 data showing that Dupixent (dupilumab) significantly improved esophageal function and reduced disease-related structural damage in adult patients with eosinophilic esophagitis (EoE), reinforcing the drug's position as the only approved biologic in the indication.
The REMODEL trial enrolled 69 adults, randomised 2:1 to Dupixent 300 mg weekly (n=46) or placebo (n=23). At week 24, the primary endpoint — change from baseline in esophageal distensibility plateau as measured by endoluminal functional lumen imaging probe (EndoFLIP) — showed a 1.28 mm improvement in the Dupixent arm versus -0.01 mm for placebo, a placebo-corrected improvement of 1.30 mm (p<0.05). The data were presented in a late-breaking oral session at Digestive Disease Week (DDW) 2026 in Washington.
What the data show
Secondary endpoint results were notably strong. The EoE Endoscopic Reference Score (EREFS), which assesses oesophageal oedema, rings, exudates, furrows and strictures on an 18-point scale, fell by 4.89 points from baseline in the Dupixent group compared with a 0.07-point increase in the placebo group — a statistically significant 4.96-point placebo-corrected reduction (p<0.0001). Histological remission, defined as peak eosinophil counts of ≤6 per high-power field, was achieved by 59% of patients on Dupixent versus 4% on placebo (p<0.0001).
Evan S. Dellon, Professor of Gastroenterology and Hepatology at the University of North Carolina School of Medicine and the study's lead author, said the magnitude of the improvement in esophageal size at six months "corresponded to the benefit that could be seen from an esophageal dilation procedure", adding that the findings strengthen the evidence for type 2 inflammation as a central driver of EoE biology.
Safety results were broadly consistent with the established Dupixent profile. Overall adverse event rates were 62% for Dupixent and 48% for placebo; there were no serious adverse events in either arm. The most common events reported more frequently on Dupixent were injection site pain and headache, each at 9% versus 4%.
Market context and regulatory read-across
EoE is a chronic progressive disease estimated to affect roughly one in 2,000 people in Western countries, and until Dupixent's approval it had no targeted biologic therapy. The REMODEL data are particularly relevant from a regulatory science perspective: Phase 4 commitments of this type, which use objective functional endpoints rather than patient-reported outcomes alone, are increasingly expected by the FDA as part of post-marketing requirements for novel biologics in rare gastrointestinal diseases. The EndoFLIP methodology is gaining acceptance as a surrogate for disease modification, and its use here as a primary endpoint may influence how future competitors design trials.
Several companies are exploring IL-13-selective antibodies and other type 2 pathway agents in EoE, including cendakimab (AstraZeneca/Receptos lineage), which reached Phase 3 but reported more modest results in earlier trials. Dupixent's dual IL-4/IL-13 blockade, its broad label across co-morbid type 2 inflammatory diseases such as atopic dermatitis and asthma, and its established global infrastructure — more than 1.4 million patients treated across all indications — represent substantial barriers to displacement.
The REMODEL trial remains ongoing, with assessments of esophageal distensibility planned at weeks 76 and 128 during an open-label extension. Those longer-term readouts will be critical to establishing whether the structural improvements observed at 24 weeks are durable and whether they translate into a reduction in esophageal dilation procedures over time — a key outcome for payers and gastroenterology clinical guidelines alike.