How Viaskin could expand options for families managing peanut allergy, with David Fleischer, MD

Positive phase 3 data from the VITESSE trial continue to shape how clinicians think about peanut allergy management in early childhood, particularly as longer-term goals move beyond strict avoidance. The pivotal study demonstrated that epicutaneous immunotherapy with the Viaskin peanut patch led to statistically significant desensitization in children aged 4 to 7 years after 12 months of treatment.

In VITESSE, 46.6% of children treated with the Viaskin peanut patch met the prespecified responder criteria at 12 months, compared with 14.8% of children receiving placebo. Responders were defined as achieving clinically meaningful increases in the amount of peanut protein tolerated during double-blind, placebo-controlled food challenges. The absolute difference in response rates was 31.8%, exceeding the prespecified efficacy threshold, with a P value of less than .001. Safety findings were consistent with prior studies, with most adverse events limited to mild or moderate local skin reactions at the patch site and no treatment-related serious adverse events reported.

David Fleischer, MD, professor of pediatrics at Children’s Hospital Colorado and global principal investigator of VITESSE, said the magnitude of desensitization observed is particularly meaningful given the low level of allergen exposure delivered through the skin.

“About 50% of patients reached that primary endpoint, meaning that they were desensitized by this product,” Fleischer said. “The amount of peanut they tolerated before the therapy increased after a year of therapy, and about 50% of those patients significantly, showing that the therapy really is a safe and effective therapy.”

The trial enrolled children who reacted to 150 mg of peanut protein or less at baseline, a population at risk for reactions from trace or accidental exposures. Fleischer noted that for many families, the goal is not necessarily to consume peanut, but to reduce the severity of unintended reactions.

“There are a lot of patients that just want the protection of desensitization,” he said. “They don’t want to eat the peanut. They just want to know, if they accidentally eat peanut, do they have a less severe reaction or no reaction at all?”

Long-term outcomes remain an open question, as most immunotherapy studies follow patients for 3-to-5 years. Fleischer emphasized the importance of framing treatment expectations appropriately. “When you talk about immunotherapy, this is a marathon. This is not a sprint,” he said. “You’ve got to grow out of your food allergy over the years with these therapies…so be patient with it.”

Still, earlier intervention appears to matter. Prior studies suggest younger children respond more robustly to immunotherapy, a pattern that helped shape the Viaskin development program. “The earlier you start, the better you can get these patients going,” Fleischer said, adding that some children may ultimately achieve tolerance while others may remain on therapy long term for protection.

As additional analyses, publications, and longer follow-up data emerge, Fleischer said the current findings already represent meaningful progress. “The tip of the iceberg is really good data,” he said. “To see that this patch really can be safe and effective for patients is something families have been waiting for.”

Safety findings were consistent with prior studies of the patch, and DBV Technologies reported that a US biologics license application (BLA) submission remains on track for the first half of 2026.

Reference:

Ebert M. Phase 3 trial meets primary endpoint for Viaskin peanut patch in children aged 4 to 7 years. Contemporary Pediatrics. Published December 17, 2025. Accessed January 6, 2026. https://www.contemporarypediatrics.com/view/phase-3-trial-meets-primary-endpoint-for-viaskin-peanut-patch-in-children-aged-4-7-years