DBV Technologies (NASDAQ:DBVT) announced positive topline results from EPITOPE study of its drug candidate Viaskin Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years.
The Phase 3 EPITOPE study evaluated safety and efficacy of Viaskin Peanut in children ages 1 to 3 years.
DBV Technologies plans to analyse data readout from EPITOPE study further, to explore regulatory pathways for Viaskin Peanut in toddlers, considering the unmet needs and absence of approved treatments for this vulnerable population.
Dr. Pharis Mohideen, Chief Medical Officer, said, “We are thrilled by the topline results of EPITOPE, our second Phase 3 clinical trial to evaluate the safety and efficacy of Viaskin Peanut.”
The company said that the safety results were generally consistent with the prior clinical trails of Viaskin Peanut 250 μg observed in children with peanut allergy ages 4 years.
DBV Technologies is trading high 41 percent at $2.16 in the after market session.