DBV Technologies plans the initiation of its phase III clinical trial for Viaskin Peanut, after a satisfactory conclusion of the phase II. The drug candidate already achieved a positive opinion from the Paediatric Committee of the European Medicines Agency.
Both FDA and EMA desire to move forward with the development of what may be the first in class treatment for patients suffering from peanut allergy. An important milestone for the company, that aims at developing a new class of immunotherapies for patients with food allergies.
The Phase III clinical trial in peanut allergic children aged 4 to 11 is expected to begin in the last quarter of 2015. In addition to the planned pivotal study in youngsters, which is essential to support initial European Marketing Authorization Application and initial US Biologics License Application filings, DBV also intends to conduct additional separate clinical trials in younger and older patients. The French company 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.