DBV Technologies has commenced subject screening for its COMFORT Toddlers supplemental safety study, marking a significant milestone in the development of the Viaskin Peanut patch for young children with peanut allergies. The first subject was screened at the Respiratory Medicine Research Institute of Michigan, with Dr. Jeffrey Leflein serving as Principal Investigator.
The Phase 3 double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of the Viaskin Peanut patch 250 μg in peanut-allergic children ages 1-3 years old. COMFORT Toddlers will enroll approximately 480 subjects at approximately 80-90 study centers across the United States, Canada, Australia, UK and Europe.
Study Design and Timeline
COMFORT Toddlers is structured as a six-month treatment period followed by an optional 18-month open-label treatment phase. This design will generate up to 24 months of active treatment data for participants randomized to the active group, or 18 months for those initially assigned to placebo. The study is designed to supplement safety and efficacy data from the completed Phase 3 EPITOPE study conducted in the same patient population.
"The initiation of subject enrollment in COMFORT Toddlers reinforces our commitment to peanut-allergic children and their families and is an important step in generating the data needed to potentially advance the Viaskin Peanut patch to market," said Dr. Leflein.
Multi-Site Activation
Beyond the Michigan site, additional centers have been activated for recruitment. Dr. Doug McMahon at the Allergy and Asthma Center in Maplewood, Minnesota, and Dr. Jason Ohayon at Hamilton Allergy and Immunology Clinic in Ontario, Canada, are currently open to recruitment and scheduling screenings.
Dr. Julie Wang, Professor of Pediatrics at the Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai and Global Principal Investigator for COMFORT Toddlers, emphasized the clinical need: "The interest we've seen to date further reinforces the significant unmet need that exists for this specific subject cohort."
Regulatory Pathway and Timeline
The data generated from COMFORT Toddlers will support the submission of a Biologics License Application anticipated in the second half of 2026 under the FDA's Accelerated Approval Pathway, as previously agreed upon with the agency.
"We believe the data generated through the COMFORT Toddlers study will complete the data set necessary for a Biologics License Application submission to the FDA," stated Daniel Tassé, CEO of DBV Technologies. "DBV is committed to advancing the development of Viaskin Peanut. Our patients and their families are counting on us."
VIASKIN Technology Platform
The VIASKIN patch technology represents a novel approach to food allergy treatment through epicutaneous immunotherapy (EPIT). The patch is designed to introduce microgram amounts of biologically active compounds to the immune system through intact skin, seeking to modify underlying allergies by re-educating the immune system to become desensitized to allergens through the skin's immune tolerizing properties.
DBV Technologies is currently focused on investigating VIASKIN patch technology for food allergies, which affect millions of people including young children and are characterized by symptoms ranging from mild reactions to life-threatening anaphylaxis. The company's food allergy programs include ongoing clinical trials of VIASKIN Peanut in both peanut allergic toddlers (1-3 years) and children (4-7 years).
