DBV Technologies Announces New England Journal of Medicine Publication of Phase 3 EPITOPE Trial Data Evaluating Viaskin Peanut in Toddlers

Montrouge, France, May 10, 2023

DBV Technologies Announces New England Journal of Medicine Publication of Phase 3 EPITOPE Trial Data Evaluating Viaskin Peanut in Toddlers

• The New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT^TM) with Viaskin Peanut was statistically superior to placebo in desensitizing children to peanut by increasing the peanut dose that triggers allergic symptoms.
• As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years.
• DBV is advancing regulatory efforts for Viaskin Peanut in toddlers ages 1 – 3 years old with a confirmed peanut allergy.
  
  

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that its Phase 3 EPITOPE trial of epicutaneous immunotherapy (EPIT) with Viaskin Peanut in children 1 – 3 years was published in the New England Journal of Medicine, reinforcing the potential of a new food allergy treatment option for this community.

“We are thrilled to see the EPITOPE Phase 3 data published in the New England Journal of Medicine, highlighting exciting results for toddlers with peanut allergy and their loved ones,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “This publication comes shortly after receiving pre-BLA feedback from the FDA, which outlined the regulatory path for our Viaskin Peanut program in 1 – 3-year-olds. Parents and caregivers are eagerly awaiting FDA-approved treatment options for this age group. We are pleased that the NEJM has confirmed what we know to be true: the EPITOPE data represent a ‘next step towards a future with more [approved] treatments for food allergies.’.”¹

Peanut allergy is the most common food allergy in children in the United States, with growing prevalence and increasing impact on patients, families, and health systems. Despite this substantial burden, there are limited treatment options for peanut allergy and no FDA approved options for children younger than 4 years of age.

Viaskin Peanut, a novel form of EPIT, has the potential to offer a new and breakthrough science that modifies an individual’s underlying food allergy by re-educating the immune system to increase tolerance to allergens. As stated in the article “the developing immune system may be particularly amenable to desensitization, which provides an important rationale for prioritizing treatments that target younger children.”