Late-stage biopharmaceutical company DBV Technologies has officially announced the screening of its first participant in the THRIVE Phase 2 clinical study. This first-of-its-kind trial is designed to evaluate the efficacy and safety of the company’s proprietary VIASKIN® Peanut Patch in infants ages 6 through 12 months with peanut allergy.
The study is designed to assess whether the VIASKIN Peanut Patch can help these infants achieve long-term tolerance of dietary peanut—meaning they would eventually be able to eat peanut-containing foods as desired without following a prescribed dosing schedule. The first participant was screened by Dr Douglas Mack, an Assistant Clinical Professor in the Department of Pediatrics at McMaster University in Ontario, who serves as a principal investigator for the trial.
Medical experts believe that treating food allergy at such an early stage of life could yield unique benefits. “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,” Dr Mack explained regarding the trial’s significance.
He further expressed his enthusiasm for the project, noting the unique biological advantages of treating patients at this stage of development. “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,” he added, stating that he expects the study to provide crucial insights into early food allergy intervention.
The THRIVE trial is structured as a Phase 2, single-arm, open-label study. Over a 36-month period, all participating infants will wear the VIASKIN Peanut Patch daily while adhering to a strict peanut-free diet. After three years, researchers will conduct a food challenge to evaluate each participant’s tolerance and establish an individualized peanut consumption plan for the following 12 months. Based on their response to the food challenge, some participants may be considered to have achieved ad lib peanut consumption during the study’s fourth year, while others may continue patch therapy or discontinue treatment altogether.
DBV Technologies aims to build on its existing clinical successes in slightly older age groups. Daniel Tassé, Chief Executive Officer, noted that the initiation of screening marks a major stride forward in the company’s mission to transform the lives of families managing peanut allergy. He highlighted that the study builds upon positive trial results previously observed in toddlers ages 1 through 3 years and children ages 4 through 7 years.
Tassé emphasized the underlying philosophy of the company’s research, pointing toward the long-term potential of the product candidate. “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,” Tassé stated.
