Pharmaceutical Business review

DBV Technologies enrolls first patient in Phase IIA study in pediatric eosinophilic esophagitis

The Viaskin Milk patch is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that can deliver biologically active compounds to the immune system through intact skin without allowing compound passage into the blood.

The SMILEE trial is conducted under an Investigational New Drug (IND) application held by Dr. Jonathan Spergel at The Children’s Hospital of Philadelphia.

It is estimated that EoE, a chronic disease, affects one in every 2,000 children. EoE is a serious condition, which causes the swelling of the esophagus triggering severe symptoms such as vomiting, abdominal pain, regurgitation, dysphagia, and in young children and infants, feeding difficulties and failure to thrive. Many studies suggest that food allergies are the main cause of EoE in children, including allergy to cow’s milk.

If left untreated, EoE may cause acute and chronic complications including food impaction, esophageal stricture, narrow-caliber esophagus, and esophageal perforation.

DBV Technologies chairman and CEO Pierre-Henri Benhamou said: "The launch of SMILEE isyet another step forward in DBV’s commitment to improve the life of patients suffering from food allergies. EoE is a debilitating and painful condition, and while we are still learning about its long-term impact, if left untreated, EoE may cause permanent damage to the esophagu.,

"With the epicutaneous approach, it is potentially the first time that Specific Immunotherapy can be used to switch off the process of eosinophilic infiltration responsible of EoE. This new concept has the potential to transform the management of the patients suffering from EoE."