DBV Technologies Announces Additional Positive Results from Its Peanut Allergy Patch
DBV Technologies revealed encouraging supplementary data from its phase 3 VITESSE trial at the annual congress of the American Academy of Allergy, Asthma, and Immunology (AAAAI) in Philadelphia. These results support a planned FDA approval request in the first half of 2026.
Significant Achievements in the VITESSE Study
DBV's VIASKIN Peanut patch met its primary endpoint in the VITESSE study, the largest trial to date in food allergy immunotherapy. After 12 months of treatment in children aged four to seven years with peanut allergies, 46.6% of the children in the VIASKIN Peanut group responded to the treatment, compared to 14.8% in the placebo group. The therapeutic effect was statistically significant, with a p-value less than 0.001 and a response rate difference of 31.8%, exceeding the predefined minimum threshold of 15%. These results suggest a broad and consistent therapeutic effect, regardless of the initial characteristics of the patients.
Clinical Increase in Reactogenic Dose
The additional data presented at the AAAAI highlighted a clinically significant increase in the reactogenic dose among treated children, indicating a potential reduction in the risk of allergic reaction. Conversely, nearly four times as many children in the placebo group recorded a decrease in their reactogenic dose over the twelve-month period, making them more sensitive to the allergen. DBV Technologies plans to submit a Biologics License Application (BLA) to the FDA in the first half of 2026, potentially offering a non-invasive therapeutic option that easily integrates into patients' daily activities.
About DBV Technologies
DBV Technologies is an advanced-stage biopharmaceutical company specializing in the development of treatments for food allergies and other immune disorders. The VIASKIN patch utilizes epicutaneous immunotherapy (EPIT), a novel class of non-invasive treatment designed to alter the allergic reaction by re-educating the immune system to desensitize to the allergen. DBV Technologies' global headquarters is located in Châtillon, France, and its North American operations are based in Warren, New Jersey.
