DBV Peanut Patch Phase 3 Data: 46.6% Response in Children 4-7 vs 14.8% on Placebo, 96.1% Compliance
DBV Technologies announced on November 12 that new data from the Phase 3 VITESSE trial of its VIASKIN Peanut Patch will be presented at the American College of Allergy, Asthma and Immunology (ACAAI) 2026 Annual Scientific Meeting in Phoenix, with three presentations supporting the patch's safety and efficacy in children aged 4 to 7 with peanut allergy across reaction severity, immunologic changes and everyday practicality.
VITESSE is the largest food allergy immunotherapy trial to date, randomizing 654 children 2:1 to the VIASKIN Peanut Patch containing 250 micrograms of peanut protein or placebo for 12 months. The study met its primary endpoint: at month 12, 46.6% of children in the patch arm met treatment responder criteria, versus 14.8% on placebo, a difference in response rates of 31.8%, 95% confidence interval 24.5% to 39.0%, p less than 0.001.
The new data show that at the month 12 double-blind, placebo-controlled food challenge, maximum symptom severity was significantly lower with the patch (p=0.004): severe reactions occurred in 8.4% of patch-treated participants versus 12.5% on placebo, and 12.5% of patch-treated participants had no or mild symptoms versus 1.5% on placebo. When reactions were assessed at or below each participant's baseline eliciting dose, 52.7% of patch-treated participants had no symptoms versus 19.2% on placebo, while moderate or severe reactions occurred in 14.0% versus 50.0%. Immunologically, peanut-specific IgG4 rose by month 3 and stayed elevated through month 12, peanut-specific IgE and Ara h 2-specific IgE were significantly lower at month 12, and skin-prick-test wheal diameter decreased significantly.
On everyday use, mean treatment compliance was 96.1% with the patch and 96.5% with placebo; 83.4% of participants rated patches "very easy" or "easy" to remove and 71.9% rated removal "not painful," and participants continued typical daily activities including bathing, sports and swimming, with no restrictions on daily activities or concomitant medication use required by the protocol. Chief Medical Officer Pharis Mohideen said the data add context to the study's overall positive results, with immunologic changes consistent with other forms of allergen immunotherapy.
The VIASKIN Peanut Patch uses epicutaneous immunotherapy, delivering microgram amounts of an active compound through intact skin to re-educate the immune system to become desensitized to the allergen. DBV said the patch has not been authorized for sale in any country and remains in clinical trials. Related: Aravax Peanut Allergy Therapy PVX108 Meets Phase 2 Primary Endpoint: Tolerated Dose Up 2.4-Fold vs 1.2-Fold in Children (Source: DBV Technologies)
Source: DBV Technologies
Published by GSM · USA (original Chinese edition)
Photo: 图：过敏皮肤点刺试验示意。美国国家卫生研究院（NIH）供图，公共领域。 / Image: Allergy skin prick test. Photo courtesy of the National Institutes of Health (NIH), public domain.
