DBV:FDA Accepts IND For Trial Using Viaskin Milk In Milk-Induced EoE In Children

(RTTNews) - DBV Technologies (DBVT), a clinical-stage specialty biopharmaceutical company, Wednesday said the U.S. Food and Drug Administration has accepted an investigator-sponsored investigational new drug application for a Phase IIA clinical trial for the potential treatment of milk-induced eosinophilic esophagitis or 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. It 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.