IND acceptance for milk-induced eosinophilic esophagitis treatment

The US Food and Drug Administration (FDA) has accepted an investigator-sponsored investigational new drug (IND) application for a Phase IIA clinical trial for the potential treatment of milk-induced eosinophilic esophagitis (EoE) in children using DBV Technologies' Viaskin milk.

This IND acceptance enables Dr. Jonathan Spergel at The Children's Hospital of Philadelphia to initiate SMILEE (study efficacy and safety of Viaskin milk in milk-induced eosinophilic esophagitis), a clinical trial designed to assess the efficacy and safety of Viaskin milk in children four to 17 years of age suffering from milk-induced EoE. 

EoE is a recently recognised allergic inflammatory disease, characterised by swelling of the esophagus. Typical symptoms include vomiting, abdominal pain, regurgitation, dysphagia and in young children and infants, feeding difficulties and failure to thrive. 

SMILEE is expected to be a double-blind, placebo-controlled, randomised 3:1 trial, designed to evaluate the safety and efficacy of Viaskin milk 500 for treating milk-induced EoE in children. Subjects with a documented medical history of EoE after ingestion of milk who currently adhere to a strict milk-free diet will be considered for participation in the trial.

Approximately 20 subjects, 15 in the treatment group and five in the placebo group, will be randomised and treated for nine months while remaining on a milk-free diet. The treatment group will then continue the trial during a milk reintroduction period (1 week to 2 months), for a total of up to 11 months of treatment.

The primary efficacy endpoint will be evaluated as the maximum esophageal eosinophil count in the treatment group compared with placebo at the end of treatment. Secondary efficacy endpoints will include the change in symptoms score at the end of treatment compared to baseline and mean esophageal eosinophil count at the end of treatment.