Viaskin Peanut is the first immunotherapy product specifically developed by DBV Technologies. Through its peanut specific EPIT technology, Viaskin® Peanut aims to safely desensitize/tolerize peanut allergic subjects to peanut by increasing the level of peanut proteins consumed symptom-free, consequently protecting them from severe systemic reactions in case of accidental ingestion of peanut.
An American nationwide clinical investigation has demonstrated that about 1.1% of the general population of the US, that is over 3 million people, are allergic to peanut and/or to nuts. Two recent studies in the U.K. and U.S. have shown that peanut allergies have doubled over a 5-year span. Peanut allergy is one of the principal sources to severe and even deadly reactions to food allergies, making it one of the major sanitary concerns worldwide, and particularly in developed countries which has witnessed it increasing prevalence in the past decade. 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.
To date, there are no existing desensitization treatments on the market for food allergies such as peanut allergy.
Using its epicutaneous delivery system, VIASKIN®, DBV Technologies’ EPIT aims to desensitize allergy patients while minimizing risk of anaphylactic reactions. DBV Technologies’ VIASKIN® ensures adequate amounts of the allergen are delivered to the immune competent cells in the epidermis without breaking the blood-skin barrier, thereby dramatically reducing the risk of anaphylactic shock.
DBV Technologies began clinical investigations at several medical centers in the U.S during 2010, including 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. This study has successfully concluded and will allow DBV to pursue the next clinical stages, and begin stage IIb/III in early 2012 that will take place in Europe as well as in the United States.
For more information on these trials, please contact Pierre-Henri Benhamou.
Pre-clinical EPIT studies have demonstrated positive results both in terms of efficacy and tolerance in mouse and guinea pig models sensitized to different types of allergens, including peanut. During these preclinical trials, no local or systemic clinical signs other than the local cutaneous reactions were reported during the course of treatment, suggesting the safety of the epicutaneous repeated applications of potentially lethal doses of peanut proteins using VIASKIN®. To view research supporting DBV Technologies peanut allergy EPIT program, please click here.
The development of VIASKIN Peanut is also supported by the CoFar (the U.S. Consortium of Food Allergy Research), supported financially by the NIH (U.S National Institute of Health) as well as by American opinion leaders on allergies.
A Stage II clinical trial is taking place in different centers. This study is sponsored by AP-HP
