Aimmune Therapeutics, Inc. announced that it has enrolled the first patient in the pivotal Phase 3 PALISADE trial of its lead product candidate, AR101 for the treatment of peanut allergy. More than five million people in the United States and Europe have peanut allergy, an increasingly prevalent, potentially life-threatening, chronic condition for which there are no approved treatments. PALISADE is an international, randomized 3:1, double-blind, placebo-controlled, Phase 3 trial of the efficacy and safety of AR101 in a characterized desensitization (CODIT™) approach in patients with peanut allergy.

Aimmune expects PALISADE to enroll approximately 500 peanut-allergic patients 4-55 years of age at more than 60 clinical sites in the United States, Canada, and nine countries in the European Union. Aimmune expects to complete enrollment in PALISADE in the second half of 2016 and complete the trial in the second half of 2017. PALISADE will evaluate the safety and efficacy of AR101 for desensitizing peanut-allergic patients to a level sufficient to reliably protect them from allergic reactions upon accidental exposures to peanut.

Under the PALISADE protocol, patients will undergo a dose escalation period of approximately 22 weeks to reach the maintenance dose of 300 mg per day, then continue with daily maintenance at 300 mg per day for approximately six months. At the end of the maintenance period, patients will undergo an exit double-blind, placebo-controlled food challenge (DBPCFC).