DBV Technologies Announces It Has Screened The First Subject In COMFORT Toddlers Supplemental Safety Study In Peanut Allergic Toddlers 1 – 3 Years Old

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

• First subject screened at the Respiratory Medicine Research Institute of Michigan with Dr. Jeffrey Leflein acting as Principal Investigator
• Additional sites, including Allergy and Asthma Center of Minnesota and Hamilton Allergy and Immunology Clinic of Ontario, Canada have been activated and are scheduling screenings

DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, today provided an update on the progress on the Company's COMFORT Toddlers supplemental safety study using 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 U.S., Canada, Australia, UK and Europe. Principal Investigator, Jeffrey Leflein, MD, FAAAAI, FACAAI from the Respiratory Medicine Research Institute of Michigan, in Ann Arbor, Michigan screened the first subject in the study. Additionally, Dr. Doug McMahon, MD, Allergy and Asthma Center in Maplewood, Minnesota and Dr. Jason Ohayon, MD, Hamilton Allergy and Immunology Clinic in Ontario, Canada have been activated and are currently open to recruitment.

"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," said Dr. Leflein. "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."

COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) safety study designed to supplement the safety and efficacy data from the completed Phase 3 EPITOPE study in the same population. The study duration will be six months followed by an optional 18-month open-label treatment phase, to generate up to 24 or 18 months of active treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively.

"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," stated Julie Wang, MD, FAAAAI, FACAAI, Professor of Pediatrics, Jaffe Food Allergy Institute, the Icahn School of Medicine at Mount Sinai and Global Principal Investigator for the COMFORT Toddlers study. "The interest we've seen to date further reinforces the significant unmet need that exists for this specific subject cohort."

"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," said Daniel Tassé CEO, DBV Technologies. "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."