DBV Confirms Initiation Of Viaskin Peanut Global Phase III Trial In Children

(RTTNews) - DBV Technologies (DBVT), a clinical-stage specialty biopharmaceutical company, announced the completion of its End-of-Phase II meeting with the U.S. Food and Drug Administration or FDA.

The outcome of this meeting on the clinical development plan for Viaskin Peanut is consistent with the previously announced positive opinion of the Paediatric Committee of the European Medicines Agency (EMA) on Viaskin Peanut's Paediatric Investigation Plan (PIP).

Based on these regulatory consultations, DBV 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.

Based on these consultations, additional development plans for Viaskin Peanut in younger and older patients will be discussed with the FDA in the second half of 2015.

In children 4-11 years of age, 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 in peanut allergic children aged 4 to 11, which is essential to support initial European Marketing Authorization Application (MAA) and initial US 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 expected to start in the fourth quarter of 2015.