Sanofi and Regeneron have announced positive results from a phase 3 trial assessing the investigational use of Dupixent (dupilumab) in children aged one to 11 years with eosinophilic oesophagitis (EoE).
In the phase 3 trial, 102 children aged between one and 11 years were randomised to receive Dupixent in either a higher dose or lower dose regimen based on body weight. At 16 weeks, 68% of children on the higher dose, and 58% on the lower dose of Dupixent ‘achieved the primary endpoint of significant histological disease remission’.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. The treatment has currently received regulatory approvals around the world for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps or EoE in different age populations.
In May 2022, the US Food and Drug Administration (FDA) approved Dupixent as a 300mg weekly dose to treat patients with EoE aged 12 years and older and weighing at least 40kg.
EoE is a chronic inflammatory disease that damages the oesophagus and prevents it from working properly. In children, common symptoms include vomiting, acid reflux, abdominal discomfort and trouble swallowing.
There are currently no approved treatments for children with EoE under the age of 12. Diet adjustment is the standard treatment, as well as the use of unapproved treatments including proton pump inhibitors, swallowed topical corticosteroids and, in severe cases, a feeding tube to ensure proper caloric intake.
Of the approximately 21,000 children under the age of 12 in the US currently being treated for EoE, about 9,000 do not satisfactorily respond to the unapproved therapies they have been treated with and potentially require advanced therapy.
Commenting on the positive results, George Yancopoulos, president and chief scientific officer at Regeneron, said: “Dupixent is the first medicine to alleviate key signs of EoE in children as young as one year of age in a phase 3 trial.
“EoE can turn the basic and life-sustaining act of eating into a painful experience at a point in children’s lives when proper nutrition and achieving a healthy weight is critical to ensuring they grow and thrive. The positive results from this phase 3 paediatric trial show Dupixent has the potential to improve signs of EoE and support healthy weight gain in children from their first birthday.”