Aimmune's Peanut Allergy Product Hits Primary Endpoints in European Phase III Trial

Brisbane, Calif.-based Aimmune Therapeutics announced that its Phase III European clinical trial of AR101 for treatment of peanut allergy met its primary efficacy endpoint. In November 2018, the company had announced the publication of its successful Phase III PALISADE clinical trial of AR101 in the New England Journal of Medicine (NEJM). AR101 is 12 percent defatted peanut flower using a Good Manufacturing Process (GMP). The idea is that by exposing people, usually children, who are allergic to peanuts, to AR101 under controlled circumstances, they can be desensitized to the allergen. About 2.5 percent off all children in the U.S. might have a peanut allergy, and according to the American College of Allergy, Asthma, and Immunology, the incidence of peanut allergies in children in the U.S. has risen 21 percent since 2010. The European clinical trial, ARTEMIS, enrolled 175 children and adolescents ages 4 to 17 from 18 sites in France, Germany, Ireland, Italy, Spain, Sweden, and the UK. They went through about six months of dose escalation and then three months of a daily therapeutic dose of AR101 at 300 mg or placebo. This was followed by an exit double-blind, placebo-controlled food challenge. In other words, they were fed a peanut or peanut product to see how they reacted.