DBV Technologies Receives IND Clearance from FDA to Begin Clinical Trial in Peanut Allergy

PARIS--(BUSINESS WIRE)--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.”

More information about DBV Techologies’ peanut allergy specific EPIT® program can be found at: http://www.dbv-technologies.com/viaskin-peanut.asp

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Notes to Editors

About DBV Technologies - www.dbv-technologies.com
DBV Technologies is a private French company focused on the development of innovative products for the diagnosis and treatment of food allergies. The Company was born out of the experience of Professor Christophe Dupont, a paediatric gastroenterologist, from Assistance Publique-Hôpitaux de Paris and Université Paris Descartes, Doctor Pierre-Henri Benhamou (CEO), a paediatrician specialising in gastro-enterology, allergy and nutrition, and Bertrand Dupont, a qualified engineer from the Arts et Métiers Institute. DBV Technologies was founded in 2002 and is based in the Pépinière Paris Santé Cochin, in Paris’ 14th arrondissement.

About DBV Technologies’ Peanut Allergy EPIT programme
Through its peanut specific EPIT programme, DBV Technologies aims to safely desensitise patients suffering from peanut allergy by increasing the level of peanut proteins consumed symptom-free. The U.S. Medical Centres where patient recruitment of the first clinical trial will begin are: Duke University Medical Center, Durham, NC; The National Jewish Medical & Research Center, Denver, CO; Arkansas Children’s Hospital Research Institute, Little Rock, AR, Aspen CR, Orem, UT; and CRI Worldwide, Willingboro, NJ.

According to the American Academy of Allergy Asthma & Immunology statistics, peanut allergy is one of the most prevalent food allergies in the U.S. with over 2 million people suffering from this allergy. In the U.S. alone, food allergies are responsible for about 100,000 emergency room visits and 150-200 deaths per year, fatal food anaphylaxis being most often caused by peanuts. Due to the potentially fatal consequences of peanut allergy, this condition represents a major health concern worldwide and imposes severe social and quality of life restrictions on afflicted individuals.

DBV Technologies has already published strong pre-clinical data supporting its peanut allergy EPIT programme. These are available for review on the Scientific Publications page on the DBV Technologies website. To date, no food allergy desensitisation treatments are currently marketed for the treatment of food allergies such as peanut allergy.

About VIASKIN^®
DBV Technologies’ patented VIASKIN^® technology is a unique delivery system which retains active compounds on a carrier using electrostatic forces only. The delivery platform allows active compounds to be presented to the epidermis of the skin without breaking the blood-skin barrier. In not breaking the blood-skin barrier, DBV Technologies’ allergen diagnosis and Epicutaneous Specific Immunotherapy (EPIT) should avoid inducing systemic shock – one of the most serious concerns associated with current desensitisation therapies.