DBV Technologies (TRQX:DBVp), a late-stage biopharmaceutical company, today announced that the first participant has been screened in the THRIVE Phase 2 clinical study evaluating the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in infants ages 6 through 12 months in achieving ad lib consumption of dietary peanut.

"Recent studies such as the LEAP trial, suggest there is a critical period, or ‘window of opportunity', in food allergy treatment during which early interventions may influence the trajectory of the allergy, its management, and long-term outcomes," said Dr. Douglas Mack, Assistant Clinical Professor in the Department of Pediatrics at McMaster University and a principal investigator of THRIVE, "Given the higher immune plasticity associated with younger patients, we are very pleased this first-of-its kind study assessing the efficacy and safety of the VIASKIN® Peanut Patch in this very young population is now underway. We expect THRIVE will provide important insights into early intervention with the VIASKIN® Peanut Patch in infants with peanut allergy. I look forward to contributing to this important research in collaboration with DBV and the peanut allergy community."

THRIVE is a Phase 2, single-arm, open-label study to assess the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in infants ages 6 through 12 months with peanut allergy. All participants will have the VIASKIN® Peanut Patch applied daily for 36 months while maintaining a peanut-free diet. At 36-months, a peanut food challenge will be conducted to determine the peanut consumption regimen for the next 12-months (months 37-48 of the study). Depending on the results of the peanut food challenge, some participants will enter the 12-month peanut consumption period without further VIASKIN® Peanut Patch treatment, while others will continue to wear the patch.

"Ad lib" peanut consumption is defined in the protocol using prespecified criteria based on tolerated single-sitting intake, longitudinal consumption patterns, and caregiver-reported outcomes. Based on individual participant tolerability to peanut consumption, some participants may be considered to reach "ad lib" peanut consumption (i.e., consuming peanut as much and as often as desired) during the fourth year of the study.

"Initiation of participant screening in the THRIVE study marks an important step forward in our mission to fundamentally transform the lives of children and families living with the daily burden of peanut allergy," said Daniel Tassé, Chief Executive Officer of DBV Technologies. "Building on the positive clinical trial results we observed in toddlers aged 1 through 3 years and children aged 4 through 7 years, we are excited to expand our clinical program into this youngest patient population. We believe that early, non-invasive intervention with the VIASKIN® Peanut Patch has the potential to alter the trajectory of peanut allergy in this infant population, and data from the THRIVE study, if successful, will be critical in validating this approach."