DBV Technologies

IND Acceptance from FDA for a proof-of-concept trial using Viaskin® Milk in Milk-Induced Eosinophilic Esophagitis in Children

Press Release Bagneux, France, July 8, 2015

IND Acceptance from FDA for a proof-of-concept trial using Viaskin^® Milk in Milk-Induced Eosinophilic Esophagitis in Children

DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage specialty biopharmaceutical company, today announced that the U.S. 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 the Company's Viaskin Milk. This IND acceptance enables            Dr. Jonathan Spergel at The Children's Hospital of Philadelphia to initiate SMILEE (Study Efficacy and Safety of the 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. The SMILEE trial is expected to begin in the second half of 2015.

SMILEE is expected to be a double-blind, placebo-controlled, randomized 3:1 trial designed to evaluate the safety and efficacy of Viaskin® Milk 500 microgramme 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 randomized 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 to 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.