Aimmune announces global enrollment completion of phase 3 AR101 PALISADE trial
Aimmune Therapeutics announced it has completed global enrollment of its Phase 3 PALISADE trial of AR101 for the treatment of peanut allergy, with the total randomized to the trial expected to be approximately 540 patients. AR101 is Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. Aimmune continues to expect topline data from PALISADE in 4Q17, followed by regulatory submissions for marketing approval of AR101 in 2018 in both the U.S. and Europe. The company announced completion of North American enrollment in PALISADE in September, ahead of schedule and above target enrollment. Aimmune also announced ARTEMIS, a new dedicated European clinical trial of AR101 in peanut-allergic children and adolescents. ARTEMIS is designed to expand the data available on the efficacy profile of AR101 by exploring a higher level of protection after a shorter treatment period in a broader group of patients than in PALISADE. The primary efficacy endpoint in this new trial will be tolerating a cumulative amount of 2,043 mg of peanut protein in an exit double-blind, placebo-controlled food challenge after approximately nine months of treatment with AR101. ARTEMIS is a randomized, double-blind, placebo-controlled trial in peanut-allergic children and adolescents ages 4-17. The inclusion criteria for the trial will allow for baseline toleration of a cumulative amount not exceeding 144 mg of peanut protein in an entry DBPCFC. Patients will undergo approximately six months of up-dosing and then three months of maintenance therapy at 300 mg of AR101 per day, followed by an exit DBPCFC. Aimmune expects ARTEMIS to enroll between 120 and 160 patients at multiple sites in Europe, beginning in mid-2017.