Global study shows promising results for young children with peanut allergies

Published

Wednesday, May 10, 2023 - 12:00 PM

A study has found after one year of wearing a Viaskin Peanut epicutaneous immunotherapy (EPIT) patch, that young children had decreased  likelihood of experiencing an allergic reaction following accidental peanut exposure.

The results of the Phase 3 EPITOPE trial, sponsored by DBV Technologies, a clinical-stage biopharmaceutical company, were recently published in the New England Journal of Medicine.

Professor Kirsten Perrett, Director of the National Allergy Centre of Excellence and Population Allergy Group Lead at Murdoch Children’s Research Institute, is a co-author on this publication, having participated as a Principal Investigator in this global study. Murdoch Children’s  Melbourne was one of the Australian sites recruiting families to take part in the revolutionary treatment trial along with the Sydney Children’s Hospitals Network, Telethon Kids Institute, Perth and Women's and Children's Hospital, Adelaide.

Viaskin is a novel form of EPIT, a potential new class of treatment that harnesses the immune properties of the skin. Viaskin Peanut has the potential to help modify individuals’ underlying food allergy by desensitising the immune system to an allergen. Viaskin Peanut is currently under clinical investigation and is not yet approved by the Australian Therapeutic Goods Administration, U.S. Food and Drug Administration or any other regulatory agencies.

“These results are important for families of young children living with peanut allergies because there are currently no approved treatment options,” Prof Perrett said.

If approved, Viaskin Peanut would provide an additional treatment option to offer patients and families for whom the standard of care alone—allergen avoidance and use of rescue medication—may not be enough.

EPITOPE was a Phase 3, randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of Viaskin Peanut in children aged 1 through to 3 years of age with a diagnosed peanut allergy. The EPITOPE trial was designed to allow participants to go about their normal daily activities without restrictions.

After one year of treatment, Viaskin Peanut resulted in statistically superior desensitisation 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 (AEs) 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 desensitisation compared with placebo, sufficient to decrease the likelihood of experiencing an allergic reaction following accidental peanut exposure,” A/Prof Perrett said.

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

Children who completed EPITOPE were enrolled in the open-label follow-on study, EPOPEX, where they continued to wear a Viaskin Peanut patch daily for up to three years. This study will assess the clinical benefit after three years of EPIT to induce or maintain desensitisation to peanut in  children with peanut allergy.

Learn more