Eosinophilic Esophagitis (EoE) is an allergic disease of the esophagus, most commonly triggered by cow’s milk. There are no currently approved FDA treatment options for the management of EoE.
DBV is exploring Viaskin Milk for the treatment of cow’s milk-induced EoE in children.
SMILEE (Study of Efficacy and Safety of Viaskin Milk for Milk-induced EoE)
SMILEE was a double-blind, placebo-controlled, randomized phase 2a study sponsored by the Children’s Hospital of Philadelphia (CHOP) to assess the efficacy and safety of Viaskin Milk in cow’s milk-induced EoE. The study enrolled 20 subjects aged 4–17 years in the blinded period, of which 19 subjects were enrolled in the open-label extension.