Aimmune says over 97% of patients in PALISADE trial completed up-dosing
Aimmune Therapeutics announced that, in the ongoing Phase 3 PALISADE trial of AR101, more than 97% of patients currently on study have completed up-dosing. AR101 is Aimmune's proprietary, investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. PALISADE is a double-blind, placebo-controlled trial designed to investigate the efficacy and safety of AR101 in peanut-allergic children, adolescents, and adults. A total of 554 peanut-allergic patients, ages 4-49, were randomized to receive either AR101 or placebo for approximately six months of up-dosing followed by six months of maintenance therapy. Aimmune remains blinded to data from the trial. Based on observations of aggregated data to date, Aimmune expects that the percentage of patients completing the entire study will be well ahead of the powering calculations behind the study design. With the vast majority of patients now successfully through up-dosing in PALISADE, Aimmune estimates that final study visits will be completed around year-end 2017, and that topline data will be available in the first quarter of 2018.