Regeneron/Sanofi announce NEJM publication of Dupixent Phase 3 EoE results

The company states: “Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced the New England Journal of Medicine, or NEJM, has published results from a positive Phase 3 trial for Dupixent, or dupilumab, in children aged 1 to 11 years with eosinophilic esophagitis, or EoE. The trial showed a greater proportion of those receiving weight-tiered higher dose Dupixent experienced significant improvements in many key disease measures of EoE, compared to placebo at week 16. Data from the trial were the basis for the U.S. Food and Drug Administration Priority Review and approval of Dupixent in children aged 1 to 11 years with EoE weighing at least 15 kg, as well as for the regulatory submission that is currently under review by the European Medicines Agency for this age group. EoE is a chronic, progressive disease associated with type 2 inflammation that is thought to be responsible for damaging the esophagus and impairing its function. Diagnosis is difficult, as symptoms can be mistaken for other conditions and there are delays in diagnosis. EoE can severely impact a child’s ability to eat and may also cause abdominal pain, trouble swallowing, heartburn, vomiting and failure to thrive. Continuous management of EoE may be needed to reduce the risk of complications and disease progression. As published, a significantly greater proportion of children receiving either a weight-tiered higher or lower dose regimen of Dupixent achieved histologic remission at week 16 in Part A of the trial, compared with placebo. Additionally, those treated with higher dose Dupixent experienced significant improvements in disease severity assessed by endoscopic measures, with improvements sustained for up to one year. Those receiving lower dose Dupixent experienced improvements that were either comparable or numerically lower than the higher dose group. Dupixent also led to a numerical improvement in body weight for age percentile by week 16 that was sustained at one year, which was evaluated as an exploratory endpoint in Part A and a secondary endpoint in Part B. Safety results were generally consistent with the known safety profile of Dupixent in adolescents and adults with EoE. Adverse events more commonly observed with Dupixent (10%) in either weight-based dosing regimen versus placebo in the trial were COVID-19, nausea, injection site pain and headache during Part A. The long-term safety profile of Dupixent in children aged 1 to 11 years through Part B was similar to that observed during Part A. In Part B, one case of helminth infection was reported with Dupixent.”