Trial focusing on children with eosinophilic oesophagitis has met its primary endpoint
A phase 3 trial assessing the investigational use of Sanofi and Regeneron’s Dupixent – also known as dupilumab – in children aged one to 11 years with eosinophilic oesophagitis (EoE) met its primary endpoint of histological disease remission at 16 weeks with both higher and lower dose weight-tiered regimens.
In the trial, 102 children aged one to 11 were randomised to receive Dupixent, in either a higher or lower dose regimen based on body weight, or placebo.
At 16 weeks, 68% of children on higher dose and 58% of patients on lower dose Dupixent achieved the primary endpoint of significant histological disease. Meanwhile, safety results were generally consistent with the known safety profile of Dupixent in its approved indication for children and adults aged 12 years
Naimish Patel, head of global development, immunology and inflammation at Sanofi, commented: “We are incredibly excited to share results from this phase 3 pivotal trial evaluating Dupixent in young children suffering from eosinophilic oesophagitis – the first ever to show positive results across a variety of primary and secondary endpoints.”
“The lack of treatment options for children living with eosinophilic oesophagitis leaves many caregivers with the stress and burden of adapting their child’s meals and their entire family’s daily schedules to ensure healthy growth and development,” he added.
George Yancopoulos, president and chief scientific officer at Regeneron, concluded: “Dupixent is the first medicine to alleviate key signs of eosinophilic oesophagitis in children as young as one year of age in a phase 3 trial. The efficacy of Dupixent demonstrates that, in this age group, as in adults, IL-4 and IL-13 are key drivers of the type 2 inflammation underlying this debilitating disease.”
EoE is a chronic inflammatory disease that damages the oesophagus and prevents it from working properly. The results seen with Dupixent in adults and children with EoE demonstrate that IL-4 and IL-13 are key drivers of the type 2 inflammation underlying this disease.
Of the approximately 21,000 children under the age of 12 in the U.S. 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.
There are currently no approved treatments for children with EoE under 12 years of age.
