Viaskin Peanut Patch Makes Comeback with Positive Phase III Results in Young Children

DBV Technologies S.A. announced positive topline results from its pivotal Phase III Vitesse clinical trial evaluating the Viaskin Peanut patch for children aged four to seven years with peanut allergy.

The Vitesse study met its primary efficacy endpoint, demonstrating a statistically significant treatment effect after 12 months of therapy with the Viaskin Peanut patch compared with placebo. 

In the trial, which enrolled 654 children four to seven years of age with peanut allergy, a higher proportion of children treated with the Viaskin Peanut patch achieved the predefined responder criteria, meaning they were able to tolerate substantially more peanut protein at one year than at baseline, compared with those who received placebo. 

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Specifically, 46.6% of children treated with the Viaskin Peanut patch met response criteria at 12 months, compared to 14.8% of children in the placebo arm. 

The difference between the treatment groups was 24.5%, which exceeded the prespecified threshold of 15%, explained DBV.

Responders were children who, after 12 months, could tolerate at least 300 mg of peanut protein (if starting at an eliciting dose, known as ED, ≤ 30 mg) or at least 600 mg (if starting at 100 mg) during a double-blind, placebo-controlled food challenge.

The ED is the amount of peanut protein that triggered an allergic reaction. 

Safety results were in line with previous Viaskin Peanut studies. The most common side effects were mild-to-moderate skin reactions at the patch site. Few children discontinued treatment (3.2% vs. 0.5% for placebo), and there were no serious treatment-related events. 

Treatment-related anaphylaxis was rare (0.5%, n = 2), with both children continuing therapy. Patch adhesion and overall compliance were high at 96.2%.

The positive results are welcome news after DBV faced several setbacks with its peanut allergy patch. In 2017, its shares fell after a Viaskin study narrowly missed its primary goal. 

The company submitted an FDA application but withdrew it in late 2018 following regulator concerns around manufacturing and quality. A 2020 attempt also fell short.

In late 2021, DBV launched a new Phase III trial to address the issues, running into a partial clinical hold in 2022.

Last year, it outlined plans to seek US and European approval for children aged one to seven, and earlier this year, secured up to $307 million in financing to support development.

The Viaskin patch uses epicutaneous immunotherapy (EPIT) to deliver tiny amounts of allergen through intact skin, aiming to retrain the immune system and reduce allergic reactions.

EPIT is a non-invasive approach designed to desensitize individuals to allergens. 

Alongside trials in the four to seven-year age group, DBV is also conducting ongoing clinical trials of Viaskin Peanut in toddlers (one to three years of age).

With the Vitesse data in hand, DBV plans to move forward with a Biologics License Application (BLA) submission to the FDA in the first half of 2026. The France-based company also anticipates that the application may qualify for Priority Review, given the earlier Breakthrough Therapy Designation. 

DBV also recently secured FDA agreement that the safety exposure data from Vitesse will be sufficient to support the BLA filing in children ages four to seven, removing the need for an additional supplemental safety study and potentially accelerating the regulatory timeline. 

Peanut allergy is a leading cause of food allergy reactions in children and can trigger severe, potentially life‑threatening responses. 

While avoidance and emergency medications like epinephrine remain standard care, immunotherapies that increase the threshold of reactivity to accidental exposures have emerged as an important new strategy in management. 

“Peanut allergy places a considerable burden on children and their families that is insufficiently addressed by current treatment options or strict avoidance,” stated David Fleischer MD, professor of Pediatrics at Children’s Hospital Colorado and global principal investigator of the Vitesse study, in a statement from DBV.

“I’m thrilled by these topline results which show a statistically significant treatment effect in children treated with the Viaskin Peanut patch. The levels of desensitization achieved in this study after one year on treatment are highly clinically meaningful and represent substantial progress towards a well-tolerated, non-invasive potential option that I believe would be welcomed into pediatric care. As a practicing allergist, I look forward to what that may mean for families managing peanut allergy every day and hope to be able to implement this treatment in my clinic, if approved.”

A well‑tolerated, patch‑based immunotherapy could offer families a significantly less invasive alternative to existing approaches. 

DBV’s stock rose sharply after the positive trial news.

“Vitesse is the largest immunotherapy clinical trial ever conducted in food allergy and we are thrilled that the resulting clinical evidence supporting the Viaskin Peanut patch is robust. With these data in hand, I am looking forward to submitting the BLA to the FDA, as planned, in the first half of 2026,” stated Daniel Tassé, CEO of DBV Technologies. 

“Thanks to the food allergy community, we are one step closer to delivering on our mission to transform the lives of children and families living with peanut allergy,” said Tassé.

Vitesse was conducted at 86 sites across the US, Canada, United Kingdom, Europe and Australia, representing the largest immunotherapy clinical trial for this patient population, according to DBV. 

After the 12-month double-blind period, children could enter an open-label extension, in which all participants receive the Viaskin Peanut patch for up to three years of treatment.