DBV Technologies Progresses in Peanut Allergy Study for Toddlers

DBV Technologies has announced advancements in its COMFORT Toddlers supplemental safety study, designed for peanut-allergic children aged 1 to 3. The first subject was screened at the Respiratory Medicine Research Institute of Michigan, led by Dr. Jeffrey Leflein. Additional sites in the U.S. and Canada are now open for recruitment.

The study aims to enroll about 480 participants across multiple countries, testing the Viaskin Peanut patch. This Phase 3 trial will be both double-blind and placebo-controlled, following the previous EPITOPE study. The study duration is six months, with an optional 18-month open-label extension.

Results from COMFORT Toddlers will support a Biologics License Application to the FDA by late 2026. DBV Technologies emphasizes the importance of this study for advancing Viaskin Peanut, a potential groundbreaking therapy for peanut allergies.