FDA accepts DBV Technologies' IND for clinical study of VIASKIN for desensitization to peanut allergy

DBV Technologies (DBV), a biotech company specializing in food allergy with innovative products for diagnosis and treatment, announced today the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application. DBV Technologies will begin clinical investigation of its lead food allergy desensitization candidate, VIASKIN® PEANUT, for the desensitization to peanut allergy. The Company expects to commence recruitment of peanut allergy patients at several medical centers in the U.S. this month.

The objectives of the clinical study are to demonstrate DBV Technologies' EPicutaneous ImmunoTherapy (EPIT) using VIASKIN® PEANUT is safe and well tolerated in both adult and pediatric peanut allergy patients, and to determine an appropriate dosing regimen for further efficacy trials.

DBV Technologies' VIASKIN® aims to desensitize food allergy patients safely while minimizing risk of systemic reactions. VIASKIN® Peanut is applied on intact skin and is completely non-invasive. VIASKIN® Peanut ensures adequate amounts of the allergen are delivered effectively to the immune competent cells in the epidermis.

DBV Technologies CEO and Co-Founder, Pierre-Henri Benhamou,MD, commented: "To date, there are no existing desensitization treatments for food allergies such as peanut allergy on the market. Peanut allergy is a source of major anxiety for patients and families, especially in the U.S. where an estimated more than two million people suffer from the allergy. The significant unmet medical need for safe and efficacious treatments of food allergies is universally well recognized, especially as in the case of life threatening peanut allergies. The commencement of this clinical trial in the U.S. is a major step forward in realizing our goal of providing patients suffering peanut allergies with an innovative, painless, safe and effective peanut desensitization treatment. VIASKIN® Peanut is the first desensitization product developed by DBV Technologies. We have additional desensitization VIASKIN® products for other food allergens in development."

SOURCE DBV Technologies

www.dbv-technologies.com