Promising results as Viaskin Peanut trial in peanut-allergic toddlers concludes

A recent trial by DBV Technologies has produced promising results for very young children with peanut allergies and their families.

The trial assessed whether Viaskin Peanut – an immunotherapy skin patch – was safe, and if it worked for children between one and three years old. Most peanut-allergic children are diagnosed between these ages, but there are currently no approved therapies for this age group.

For a successful result, toddlers intolerant to tiny amounts (10 mg or less) of peanut protein, needed to be able to tolerate 300 mg or more after 12 months. Toddlers who could already manage more than 10 mg had to be tolerant of 1,000 mg of peanut protein after 12 months.

Results:

• Did it work? Viaskin Peanut met the trial’s criteria for 67% of toddlers on the trial, compared to 33.5% in a placebo trial.
• Was it safe? 8.6% of toddlers had adverse reactions – this was most commonly mild to moderate skin reactions – compared to 2.5% in the placebo trial.

The findings matched results from other trials DBV Technologies has carried out with children aged four and over. Many of the families (88%) have opted for the toddlers to continue to benefit from the treatment by signing up for a further long-term trial.

Simon Williams, Chief Executive of the Anaphylaxis Campaign, says, “It’s easy for parents of small children to get disheartened about peanut allergy when there is such a lack of treatments. But the truth is, research and development is evolving all the time. This latest trial from DBV Technologies gives us further hope for a much brighter future for families living with peanut allergy.”

Dr Pharis Mohideen, Chief Medical Officer of DBV Technologies, said, “We are thrilled by the topline results of EPITOPE, our second Phase 3 clinical trial to evaluate the safety and efficacy of Viaskin Peanut.

“We are grateful to the toddlers and their parents, caregivers and allergists who are contributing to a brighter future by having participated in this first-of-its kind trial.”