Late-breaking positive results from a Phase 3 trial evaluating the investigational use of Dupixent (dupilumab) in children aged 1 to 11 years with active eosinophilic esophagitis (EoE) will be presented today at United European Gastroenterology (UEG) Week 2022. The data will be submitted to regulatory authorities around the world, starting with the U.S. Food and Drug Administration (FDA) in 2023. In May 2022, Dupixent 300 mg weekly was approved by the FDA to treat EoE in people aged 12 years and older, weighing at least 40 kg.

Mirna Chehade, M.D, Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine, Mount Sinai, said, “Eosinophilic esophagitis impacts a child’s fundamental ability to eat, which is especially critical in early childhood when healthy weight gain is vital to long-term health and development. These Phase 3 data support the potential of dupilumab to reduce esophageal damage - caused in part by underlying type 2 inflammation - and showed histological disease remission and signs of weight gain impacting the growth percentile for those children on higher dose Dupixent.”

Dupixent led to significant improvements in the primary efficacy measure for higher (n=37) and lower (n=31) dose groups at 16 weeks in the randomized, placebo-controlled Phase 3 trial. Among children treated with Dupixent, 68% of children on higher dose and 58% of patients on lower dose achieved the primary endpoint of significant histological disease remission, compared to 3% for placebo (both p<0.0001).

Children on the higher dose regimen also experienced significant improvements in abnormal endoscopic findings of their esophagus, with a reduction of 3.5 points compared to an increase of 0.3 points for placebo (p<0.0001). Symptomatically, higher dose Dupixent led to a numerical improvement in the proportion of days children experienced disease symptoms from baseline as reported by their caregivers compared to placebo, though not statistically significant. Additionally, a prespecified exploratory analysis was presented which found higher dose Dupixent led to a 3.09 percentile increase in body weight for age percentile from baseline, compared to 0.29 for placebo.

The potential use of Dupixent in children with EoE aged 1 to 11 years is currently under clinical development, and the safety and efficacy have not been evaluated by any regulatory authority.