Date: May 12, 2023

ATLANTA (May 12, 2023) – Researchers at Children’s Healthcare of Atlanta recently participated in the international, multicenter, Phase 3 EPITOPE trial to determine the safety and efficacy of epicutaneous, meaning “on the skin”, immunotherapy (EPIT) for children ages one to three years of who have been diagnosed with peanut allergy. The results, published in the New England Journal of Medicine, show that 12 months of treatment with DBV Technologies’ Viaskin™ Peanut patch desensitized toddlers to peanuts, decreasing the chance of experiencing an allergic reaction after an accidental peanut exposure.

Viaskin™ is a new form of EPIT, a potential new class of treatment that uses the immune properties of the skin. EPIT begins with a small dose that is increased over time by wearing the patch for longer periods of the day, until a maintenance dose is reached at which point each patch is worn 24 hours and replaced daily. EPIT using a Viaskin patch does not require physical activity restrictions around dosing and is not disrupted by illness, as is required for other forms of immunotherapy like oral immunotherapy (OIT).

Viaskin Peanut is currently under clinical investigation but has the potential to help modify young children’s food allergy by desensitizing the immune system to an allergen and would provide an additional treatment option for young patients and their families. There are currently no FDA approved treatment options for peanut-allergic children under four years of age.

Brian Vickery, MD, Director of the Food Allergy Program at Children’s, is a co-author on this publication, having participated as a site Principal Investigator in this global study.

“This new treatment approach could be a game-changer for young children suffering from peanut allergies, if it were to become approved for clinical use,” said Dr. Vickery. “Because the patch dose is given on the skin and not as a shot or an oral treatment, the risks are low, and the approach is very patient-friendly. Families of young peanut-allergic children currently have no treatment options, and often struggle with keeping their children safe during routine daily activities. If approved, EPIT may help them feel safer going about their normal daily activities and hopefully improve quality of life.”

After one year of treatment, Viaskin Peanut was superior to placebo in desensitization, with treatment responder rates of 67.0% and 33.5%, respectively. Additionally, less severe food challenge reactions were seen following 12 months of treatment. Similar to previous studies of Viaskin Peanut in children, the most common side effects were local skin reactions, which decreased in frequency and severity over time. Low rates of treatment-related anaphylaxis and epinephrine use were observed. This study demonstrated that 12 months of daily EPIT with a patch containing 250 µg peanut protein – or 1/1000th of one peanut – resulted in greater desensitization compared with placebo.

It is now estimated that 8% of children in the United States are affected by food allergies. Noting the increasing number of kids affected, Children’s, in collaboration with research partner Emory University School of Medicine, launched the Food Allergy Program in early 2018. The program is housed in the Center for Advanced Pediatrics and features onsite research units. Building a robust clinical research program is critical in Children’s continued effort to learn more about food allergies and develop new treatments for all food allergies, not only peanut.

About DBV Technologies

DBV Technologies is developing Viaskin, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, and is DBV Technologies’ method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV Technologies’ food allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).