In a significant step forward for its clinical program, DBV Technologies announced on Wednesday that the first participant has been screened in its COMFORT Toddlers supplemental safety study. The study focuses on the use of the Viaskin® Peanut patch 250μg as a potential treatment for peanut-allergic children between the ages of one and three.
The clinical trial is set to be a large-scale international effort, aiming to enroll approximately 480 subjects at 80 to 90 study centers across the United States, Canada, Australia, the UK, and Europe. The milestone first screening took place at the Respiratory Medicine Research Institute of Michigan, with Dr Jeffrey Leflein serving as the Principal Investigator. DBV also confirmed that additional sites, including the Allergy and Asthma Center in Maplewood, Minnesota, and the Hamilton Allergy and Immunology Clinic in Ontario, Canada, are now activated and open for recruitment.
Dr Leflein expressed his enthusiasm about the study’s commencement:
I am thrilled that our talented team of clinicians was the first to screen a subject for the COMFORT Toddlers supplemental safety study and we have several other potential subjects scheduled for screening. 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.
The trial is a Phase 3 double-blind, placebo-controlled (DBPC) safety study. It is designed to build upon the safety and efficacy data from the previously completed Phase 3 EPITOPE study in the same toddler population. The study’s Global Principal Investigator, Dr Julie Wang of the Icahn School of Medicine at Mount Sinai, stated:
I am very pleased subject screening has commenced in COMFORT Toddlers and look forward to working with my fellow investigators on the efficient enrollment and execution of this important study. The interest we’ve seen to date further reinforces the significant unmet need that exists for this specific subject cohort.
From the company’s perspective, the initiation of this study is a pivotal moment. Said Daniel Tassé, CEO of DBV Technologies:
Screening our first subject marks a crucial step forward in our mission to develop this potential groundbreaking therapy for food allergic patients, as we are now well underway with both of our core clinical programs. 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. DBV is committed to advancing the development of Viaskin Peanut. Our patients and their families are counting on us.
Ultimately, the data from the COMFORT Toddlers study is intended to support a Biologics License Application (BLA) submission to the US Food and Drug Administration. DBV Technologies anticipates this submission will occur in the second half of 2026, utilizing the Accelerated Approval Pathway as previously discussed with the FDA.
