DBV Technologies has announced that the first patient has been screened in its international COMFORT Toddlers study, which is evaluating the safety of the Viaskin® Peanut patch (250 μg) in children aged 1 to 3 years with peanut allergies. This marks the beginning of a key clinical effort aimed at expanding potential treatment options for a patient group with limited alternatives and considerable health risks.
The study’s initial screening took place at the Respiratory Medicine Research Institute of Michigan, under the leadership of Dr. Jeffrey Leflein. Additional sites, including the Allergy and Asthma Center of Minnesota and the Hamilton Allergy and Immunology Clinic in Ontario, Canada, have been activated and are also preparing to enroll participants. In total, COMFORT Toddlers plans to include approximately 480 subjects at 80 to 90 centers across the United States, Canada, Australia, the UK, and Europe.
COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled trial designed to supplement existing data from the earlier EPITOPE study in the same pediatric population. Participants will be followed over a six-month blinded phase with the option of continuing into an 18-month open-label period. This structure will provide up to two years of cumulative data on the use of the Viaskin Peanut patch, which delivers small amounts of peanut protein through the skin to build tolerance and help protect against accidental exposure.
The launch of this trial reflects growing attention to the challenges of managing peanut allergies in very young children. Early data have indicated the potential of this skin-applied therapy to slow or alter immune responses to peanut protein, reducing the likelihood of severe reactions. By expanding research into toddlers, DBV Technologies aims to address a critical gap in current allergy care, as this age group faces significant dietary restrictions and anxiety over unintended exposures.
Data gathered from COMFORT Toddlers are expected to support DBV Technologies’ planned Biologics License Application submission to the U.S. Food and Drug Administration, anticipated in the second half of 2026 under the FDA’s Accelerated Approval Pathway. This process would leverage both safety and efficacy results to determine whether the therapy could become an approved option for managing peanut allergies in early childhood.
As enrollment moves forward across multiple international sites, the study represents an important step toward building a more comprehensive approach to treating peanut allergy in one of the most vulnerable patient populations. The outcomes could not only shape future regulatory decisions but also inform clinical practices and bring additional hope to families managing this lifelong condition.