DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old

Core Viewpoint - DBV Technologies has initiated the COMFORT Toddlers supplemental safety study for the Viaskin® Peanut patch, targeting peanut-allergic children aged 1 to 3 years, marking a significant step towards advancing this treatment option to market [1][3][4]. Group 1: Study Details - The COMFORT Toddlers study aims to enroll approximately 480 subjects across 80 to 90 study centers in the U.S., Canada, Australia, the UK, and Europe [2]. - The study is a Phase 3 double-blind, placebo-controlled safety trial designed to supplement safety and efficacy data from the completed Phase 3 EPITOPE study [3]. - The study duration is six months, followed by an optional 18-month open-label treatment phase, allowing for up to 24 months of active treatment for participants in the active group [3]. Group 2: Investigator Insights - Dr. Jeffrey Leflein, the Principal Investigator, expressed enthusiasm about the first subject being screened and highlighted the commitment to peanut-allergic children and their families [3][4]. - Julie Wang, Global Principal Investigator, noted the significant unmet need for this specific cohort, reinforcing the importance of the study [4]. Group 3: Regulatory and Future Plans - The data generated from the COMFORT Toddlers study is expected to support a Biologics License Application (BLA) submission to the FDA, anticipated in the second half of 2026 under the Accelerated Approval Pathway [4]. - The company is focused on advancing the development of the Viaskin Peanut patch, which aims to address food allergies through epicutaneous immunotherapy [9].