Pharmaceutical company DBV Technologies announced that its Phase 3 EPITOPE trial of epicutaneous immunotherapy (EPIT) with Viaskin Peanut in children aged 1-3 was published in the New England Journal of Medicine, according to a press release. The move reinforces the idea that the company is close to offering a new food allergy treatment option.
“We are thrilled to see the EPITOPE Phase 3 data published in the New England Journal of Medicine (NEJM), highlighting exciting results for toddlers with peanut allergy and their loved ones,” said DBV CEO Daniel Tassé. “This publication comes shortly after receiving pre-BLA feedback from the FDA, which outlined the regulatory path for our Viaskin Peanut program in 1 to 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 represents a ‘next step toward a future with more [approved] treatments for food allergies.’”
Following one year of treatment, the Viaskin Peanut patch resulted in significantly higher desensitization rates compared to a placebo following one year of treatment, with treatment responder rates of 67% for Viaskin Peanut and 33.5% for the placebo. Additionally, following a year of treatment with Viaskin Peanut, subjects showed a shift toward less severe food challenge reactions.
According to DBV, peanut allergy is the most common food allergy among American children, and it has a growing impact on patients, families and health systems. However, there are only limited treatment options for peanut allergy and no FDA-approved options for children younger than 4 years of age.
Viaskin Peanut, a form of epicutaneous immunotherapy (EPIT), has the potential to offer a new and breakthrough science that involves applying a patch containing a small amount of the allergen to the skin. Over time, the patch helps the body develop a tolerance to the allergen and reduces the intensity of allergic reactions.
According to AP News, the study was conducted on 362 toddlers with peanut allergies. The Viaskin patch was placed between their shoulder blades so that they couldn't pull it off, and the subjects were randomly assigned the patch or a placebo. Following a year of treatment, the toddlers were tested again, and approximately two-thirds of those who had the Viaskin patch could safely ingest more peanuts. While 33.5% of children with the placebo showed improvements, Dr. Matthew Greenhawt said that they had likely outgrown the allergy.
Regarding safety, four Viaskin recipients experienced an allergic reaction called anaphylaxis that was deemed related to the patch. Three were treated with epinephrine to calm the reaction, and one dropped out of the study entirely.
Still, the Viaskin patch wearers experienced fewer allergic reactions than those wearing the placebos. The most common side effect of the patch was skin irritation at the patch site.
