DBV Technologies announced that based its meeting with the Food and Drug Administration (FDA), it plans to initiate a global Phase 3 study of its investigational Viaskin Peanut epicutaneous immunotherapy (EPIT) patch for the treatment of peanut allergy.
The anticipated Phase 3 trial, the Peanut EPIT Efficacy and Safety Study (PEPITES), is planned for the fourth quarter of 2015 with 260 children aged 4–11 from 35 sites in North America, Australia, and Europe. The randomized, double-blind, placebo-controlled study will assign patients to receive either Viaskin Peanut 250mcg or placebo for 12 months to evaluate the safety and efficacy in the patient population with peanut allergy. The primary endpoint will be response to Viaskin Peanut and the secondary efficacy endpoint will be the total quantity of peanut protein that triggers patient reactions at Month 12 vs. placebo.
DBV Technologies also intends to conduct separate clinical trials in younger and older patients to assess the safety and efficacy of the treatment in these patient populations. Viaskin Peanut has received Fast Track designation and Breakthrough Therapy designation from the FDA.
For more information visit DBV-Technologies.com.