DBV Technologies Announces New England Journal of Medicine Publication of Phase 3 EPITOPE Trial Data Evaluating Viaskin Peanut in Toddlers - Seite 2

The NEJM highlights that EPIT with Viaskin Peanut, as a patch-based nonoral immunotherapy option, has shown in clinical studies consistent evidence of efficacy, safety, and high treatment adherence. The EPITOPE trial was designed to allow participants to go about their normal daily activities such as playing, showering, or swimming, without restrictions.

“I see peanut-allergic patients in my clinical practice daily. I speak with parents who are experiencing increased anxiety and a decreased quality of life due to fear of life-threatening reactions,” said Matthew Greenhawt, M.D., MBA, MSc of Children’s Hospital Colorado and lead author of the publication. “This publication shows that, if approved, the Viaskin Peanut patch has the potential to give new hope to toddlers and their families who currently have no approved treatment options and must instead rely on avoidance, which can severely impact quality of life. The EPITOPE data are a meaningful advancement in potentially offering the first-ever FDA approved treatment option for peanut-allergic toddlers.”

EPITOPE was a Phase 3, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of Viaskin Peanut in children 1 through 3 years of age with a diagnosed peanut allergy.

After one year of treatment, Viaskin Peanut resulted in statistically superior desensitization compared with placebo, with treatment responder rates of 67.0% and 33.5%, respectively. Additionally, a shift towards less severe food challenge reactions was seen following 12 months of treatment with Viaskin Peanut. Similar to previous studies of Viaskin Peanut in children, the most common adverse events were local application site 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 (1/1000th of one peanut) resulted in greater desensitization compared with placebo, sufficient to decrease the likelihood of experiencing an allergic reaction following accidental peanut exposure.

Viaskin Peanut was well-tolerated by a majority of participants and had low discontinuations due to AEs and high compliance rates. Subjects were able to wear the patch daily without restrictions around activities for a sufficient duration over the course of the treatment period to induce desensitization.

“As a parent who has raised children with food allergies and as a voice for the food allergy community, I am encouraged to see the EPITOPE trial results published by the New England Journal of Medicine,” said Kenneth Mendez, CEO of the Asthma and Allergy Foundation of America and its food allergy division, Kids with Food Allergies. “Many caregivers worry about their food-allergic toddler’s accidental exposure to a food allergen. This sometimes means that they will limit their toddler from everyday activities. Caregivers need a treatment option that provides peace of mind for them and for their children. I am excited by this innovative potential treatment option and hopeful that one day, toddlers with peanut allergy will have multiple treatment options to choose from.”