DBV Technologies recently announced it has received the green light from the Food and Drug Administration (FDA) to begin a global Phase III trial using Viaskin® Peanut (also known as the “peanut patch”). This is the first time that a drug for food allergy has reached Phase III – a step in the clinical trial process during which a drug or treatment is given to a larger group of people to confirm its effectiveness and collect information that will allow it to be used safely.
The anticipated Phase III trial, Peanut EPIT Efficacy and Safety Study (PEPITES), which will enroll children ages 4 to 11, is expected to begin later this year following submission of the final clinical trial protocol and review by the FDA. PEPITES is planned as a randomized, double-blind, placebo-controlled trial with about 260 patients from 35 sites in North America, Australia and Europe.
DBV Technologies’ primary goal is to show that its therapy significantly reduces an individual’s sensitivity to peanut; this would help them avoid a life-threatening allergic reaction from accidental ingestion. This endpoint could potentially increase the study’s clinical relevance by better showing that the therapy increases safety for people with peanut allergy. This is the first specific therapy for food allergy to be approved to enter a Phase III trial, which is the final phase before consideration by the FDA for approval in the market.
The company also plans to conduct additional separate clinical trials in younger and older patients.
Earlier this year, DBV Technologies presented clinical data on the company’s Phase 2b trial, the results of which continue to support the effectiveness and safety of the peanut patch. This data showed that 50 percent of children were able to tolerate an oral challenge of at least 300 mg of peanut protein after 12 months of treatment versus 12.9 percent in the placebo arm. The study’s authors say this threshold dose of 300 mg peanut protein is clinically relevant, as reaching this level significantly reduces the risk of allergic reactions to potential peanut traces in foods.