Sanofi has announced the publication of positive results from a Phase III clinical trial of Dupixent (dupilumab) in one to 11-year-old children with eosinophilic esophagitis (EoE).
The study is designed to evaluate the efficacy and safety of Dupixent in these children.
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A fully human monoclonal antibody, Dupixent targets the interleukin-4 (IL4) and interleukin-13 (IL13) pathways without being an immunosuppressant.
The double-blind, randomised, placebo-controlled trial consisted of two parts.
Part A involved 102 patients and tested Dupixent at a weight-tiered higher or lower dose against a placebo for 16 weeks. Part B was a 36-week extension where patients continued or switched to the appropriate Dupixent dose.
Histologic remission at 16 weeks was the trial’s primary endpoint, with secondary endpoints comprising endoscopic and histopathologic assessments and disease severity, clinical signs and symptoms of EoE.
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By GlobalDataThe results indicated that a higher proportion of patients on the weight-tiered higher dose of Dupixent saw significant improvements at week 16 compared to the placebo group.
These findings supported the US Food and Drug Administration’s Priority Review and subsequent approval of Dupixent for children in this age group with EoE, weighing at least 15kg.
They are also part of the regulatory submission currently under review by the European Medicines Agency.
Dupixent was seen to be associated with a numerical improvement in body weight for the age percentile by week 16, which was sustained up to one year.
The safety profile of Dupixent in this trial was consistent with previous findings in adolescents and adults with EoE.
For US patients with EoE weighing at least 15kg, the FDA-approved dosage for Dupixent is 200mg or 300mg every other week or 300mg weekly, depending on the patient’s weight.
As part of a global partnership, Sanofi and Regeneron are jointly developing Dupilumab.
The latest development comes after Sanofi reported one-year follow-up findings from the Phase II trial of riliprubart in chronic inflammatory demyelinating polyneuropathy patients.
