DBV Technologies has announced the initiation of a Phase three study designed to evaluate the safety and efficacy of Viaskin Peanut 250g in children ages 4 to 11 with peanut allergies
The Viaskin Peanut patch is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that can deliver biologically active compounds to the immune system through the immune cells of the intact skin.
Peanut EPIT Efficacy and Safety Study (PEPITES) is an international, randomised 2:1, double-blind, placebo-controlled Phase three study, in which pediatric peanut allergic patients will be treated with Viaskin Peanut 250g or placebo for 12 months.
During the trial, patients' peanut allergy will be assessed using a double-blind, placebo controlled food challenge (DBPCFC) at baseline.
Both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have agreed to a combined primary endpoint based on a responder analysis after 12 months of treatment.
For patients with a baseline peanut protein eliciting dose (ED) equal to or less than 10mg, a responder will be defined as a patient with a peanut protein ED equal to or greater than 300mg of peanut protein after 12 months of treatment.
For subjects with a baseline ED greater than 10mg, a responder will be defined as a patient with a peanut protein eliciting dose equal to or greater than 1,000mg of peanut protein after 12 months of treatment.
PEPITES is expected to enroll approximately 330 patients in about 30 centers across North America (Canada and the United States), Europe, and Australia.
Pierre-Henri Benhamou, chairman and chief executive officer of DBV Technologies, said: "Over the last two decades, peanut allergic patients have been waiting for a treatment that could safely protect them against life-threatening anaphylaxis without causing dangerous side effects.
“If PEPITES' results are in-line with data from our previous studies, we believe that Viaskin Peanut may be poised to be the first new therapy for safely treating peanut allergy."
"We anticipate that we will complete PEPITES' recruitment as originally planned, by the end of the third quarter of 2016."