Aimmune Therapeutics Receives EMA Decision Agreeing With PIP for AR101 for the Treatment of Peanut Allergy

Aimmune Therapeutics, Inc.

, a biopharmaceutical company developing desensitization treatments for food allergies, today announced that it has received the European Medicines Agency (EMA) decision endorsing the company's pediatric investigation plan, or PIP, for AR101 for the treatment of peanut allergy. The decision follows the EMA Paediatric Committee (PDCO) positive opinion on the PIP on August 14, 2015. In Europe, an approved PIP is a required component of the EMA regulatory approval process. A marketing authorisation application (MAA) can be accepted only if the sponsor has an approved PIP and has completed the relevant studies outlined in that plan. "This positive opinion on our PIP puts us another step closer to having a treatment to desensitize patients with peanut allergy and keep them safe from dangerous reactions upon accidental exposure," said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D.. "With more than a million children in Europe living with peanut allergy, we are dedicated to bringing them a treatment that can give them and their families a significant level of protection and peace of mind in their daily lives." In June, Aimmune announced that the results of its ARC001 Phase 2 trial of AR101 for the treatment of peanut allergy demonstrated efficacy and overall safety in peanut-allergic patients (ages 4-21). In that study, 100 percent of the 23 active-arm patients who completed the study met the primary endpoint of tolerating exposure to 443 mg cumulative amounts of peanut protein, and 78 percent met an additional endpoint of tolerating exposure to 1,043 mg cumulative amounts of peanut protein. The approved PIP includes Aimmune's planned Phase 3 trial of AR101 for the treatment of peanut allergy, expected to commence in early 2016. This randomized, double-blind, placebo-controlled trial will enroll approximately 500 peanut-allergic children, adolescents and adults (ages 4-55) in the United States and Europe. The PIP also includes an additional randomized, double-blind, placebo-controlled study designed to potentially allow expansion of the age range for AR101 treatment down to one-year-old children. This additional study does not need to be completed prior to potential approval of AR101.