An innovative new product developed by French biopharmaceutical company, DBV Technologies, could transform the treatment of children who suffer from peanut allergy.
The product, called the Viaskin® Peanut Allergy Patch, is an electrostatic patch that delivers peanut protein directly onto the superficial layers of the skin. This process, defined as epicutaneous immunotherapy (EPIT), “activate[s] the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.”
Among the most common food allergies, peanut allergy can lead to serious and potentially fatal allergic reactions, including anaphylaxis. It affects an estimated 1-3% of children in many westernized countries and appears to be on the rise, with a sudden increase in the number of cases reported over the past 10 to 15 years (Fleischer, D et al. Ped. 2015; 136(3): 600-604).
The problem has become so prevalent in some areas that school districts are now prohibiting kids from bringing peanuts, peanut butter or any peanut-containing foods to school.
Standard treatment for peanut allergy consists primarily of strict peanut avoidance and easy access to injectable epinephrine.
Wood et al. note that “traditional subcutaneous immunotherapy has proven unsafe for peanut allergy, and although oral and sublingual immunotherapy have shown some promise for peanut and other food allergens, these approaches have the potential for significant adverse reactions” (Wood, RA et al. Allergy. 2013; 68(6): 803-808).
Novel treatment options for patients with lifelong, severe peanut allergy are, therefore, highly desired.
DBV conducted the first clinical trial of its peanut allergy patch in 2010, and has continued ongoing testing in coordination with the US Food and Drug Administration (FDA) since that time. The initial results of their research suggest that the patch is well-tolerated with a favorable safety and side effect profile.
Earlier this year, Viaskin® Peanut was awarded a Breakthrough Therapy Designation by the FDA. The first company to receive this FDA designation in food allergies, its breakthrough status was granted “following positive Phase IIb trial results emphasizing the need to provide a safe pharmaceutical treatment for patients suffering from life threatening food allergies.”
The company has also announced plans to initiate a Phase III clinical study to further assess the efficacy and safety of the patch.
Called PEPITES (Peanut EPIT® Efficacy and Safety Study), the study is designed as a randomized, double-blind, placebo-controlled trial including approximately 260 peanut-allergic kids from 35 sites across the United States, Canada, Australia, Ireland, and Germany. Patients will be assigned 2:1 to receive either Viaskin Peanut 250 μg or placebo for 12 months. The study is slated to begin sometime before the end of this year.
In addition to the PEPTITES study, DBV also intends to conduct additional clinical trials in both younger and older patients and, “expects that further regulatory consultation will help to optimize the clinical development plan for assessing safety and efficacy of Viaskin Peanut in these patient populations.”
Although further research is needed, the patch appears to hold great promise for the future treatment of peanut allergy.