DBV Technologies, a clinical-stage specialty biopharmaceutical company, has announced the completion of its End-of-Phase II meeting with the FDA. The outcome of this meeting on the clinical development plan for Viaskin Peanut is consistent with the previously announced positive opinion of the Pediatric Committee of the EMA on Viaskin Peanut’s Pediatric Investigation Plan (PIP).
BDBV Technologies plans to initiate a global phase III trial with Viaskin Peanut for the treatment of peanut allergic children 4 to 11 years of age in the fourth quarter of 2015. Additional development plans for Viaskin Peanut in younger and older patients will be discussed with the FDA in the second half of 2015.
The anticipated phase III trial, Peanut EPIT Efficacy and Safety Study (PEPITES) is expected to begin in the fourth quarter of 2015 following the submission of the final clinical trial protocol and updated chemistry, manufacturing and controls information, and review by the FDA, as well as review and approval of Clinical Trial Applications in the other countries where the trial is expected to be conducted.
In addition to the planned pivotal study, which is essential to support initial European Marketing Authorization Application (MAA) and initial U.S. Biologics License Application (BLA) filings, DBV also intends to conduct additional separate clinical trials in younger and older patients. DBV expects that further regulatory consultation will help to optimize the clinical development plan for assessing safety and efficacy of Viaskin Peanut in these patient populations.
PEPITES is planned as a randomized, double-blind, placebo-controlled pivotal phase III trial designed to assess the efficacy and safety of Viaskin Peanut 250μg in approximately 260 pediatric patients from 35 sites in North America (U.S. and Canada), Australia and Europe (Ireland and Germany). Patients will be randomized 2:1 to receive either Viaskin Peanut 250μg or placebo for 12 months. This planned phase III trial is designed to confirm with appropriate statistical considerations in children aged 4 to 11, Viaskin Peanut’s treatment effect that was shown during the phase IIb VIPES trial, while providing sufficient safety data to support initial registration fillings in this patient population.
During the trial, patients will be assessed using a double-blind, placebo controlled food challenge (DBPCFC). The primary endpoint for PEPITES is expected to be based on a more stringent treatment responder definition as compared to the criteria used in VIPES. The refined endpoint could potentially increase the clinical relevance by better defining the magnitude of the treatment effect. The FDA and EMA agreed to a combined primary endpoint based on a responder analysis after 12 months of treatment with Viaskin Peanut 250µg. 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.