Sanofi declares positive data from Phase III EoE treatment trial

Sanofi reported positive Phase III trial results for Dupixent (dupilumab) in children aged one to eleven years with eosinophilic esophagitis (EoE). This trial assessed the safety and efficacy of Dupixent, a monoclonal antibody targeting interleukin-4 (IL4) and interleukin-13 (IL13) pathways, without being an immunosuppressant.

The double-blind, placebo-controlled trial had two parts. Part A involved 102 patients receiving a weight-tiered dose of Dupixent or a placebo for 16 weeks. Part B extended to 36 weeks, with patients continuing or switching to the appropriate dose. The primary endpoint was histologic remission at 16 weeks, with secondary endpoints including endoscopic and histopathologic assessments.

Results showed significant improvements in the Dupixent group. These findings supported the FDA’s approval of Dupixent for children with EoE weighing at least 15kg, and are under review by the European Medicines Agency. The safety profile matched previous findings in older patients.