Dupixent Phase 4 Trial Shows 59% Histological Remission in EoE Patients
Sanofi and Regeneron’s Dupixent Phase 4 trial in 69 eosinophilic esophagitis patients delivered a 1.28 mm improvement in esophageal distensibility and 59% histological remission versus 4% for placebo. These results reinforce Dupixent’s exclusive biologic positioning in EoE and support broader clinical adoption.
1. Trial Design and Key Outcomes
The REMODEL Phase 4 trial enrolled 69 adults with eosinophilic esophagitis who received weekly 300 mg Dupixent (n=46) or placebo (n=23) for 24 weeks, achieving a 1.28 mm improvement in esophageal distensibility (p<0.05) and a 4.89-point reduction in endoscopic scores (p<0.0001). Histological remission reached 59% with Dupixent versus 4% with placebo.
2. Commercial Significance for Sanofi
Dupixent is the only approved biologic for eosinophilic esophagitis, and these data may drive broader prescribing in gastroenterology, bolstering Sanofi’s and Regeneron’s immunology franchises. Sustained efficacy and high remission rates strengthen Dupixent’s competitive positioning against alternative therapies.
3. Outlook and Next Steps
An ongoing extension will provide data through week 128 to assess long-term durability and safety, with no new serious adverse events reported so far. Investors will monitor adoption rates and upcoming data readouts to gauge potential revenue growth in the EoE indication.