Aimmune announces new clinical data on AR101 for Peanut Allergy

Aimmune Therapeutics reported additional results from its pivotal Phase 3 PALISADE trial of AR101 for the treatment of peanut allergy at the Congress of the European Academy of Allergy, Asthma, and Immunology 2018 in Munich. Aimmune previously announced that the trial met its primary and secondary efficacy endpoints in the pre-specified primary analysis of the 4-17 age cohort. Additional analyses including adults treated in the study were presented at EAACI. PALISADE enrolled a total of 554 patients ages 4-55. After approximately one year of treatment, clinical reactivity to peanut protein was assessed in an exit double-blind, placebo-controlled food challenge. The trial met its primary endpoint as 67% of AR101 patients ages 4-17 tolerated at least a 600-mg dose of peanut protein in the exit DBPCFC, compared to 4% of placebo patients. The lower-bound of the 95% confidence interval of the difference between treatment arms at the primary endpoint was 53%, greatly exceeding the pre-specified threshold of 15%. Based on these results, Aimmune plans to submit a Biologics License Application for AR101 to the U.S. Food and Drug Administration by the end of 2018, followed by a Marketing Authorisation Application to the European Medicines Agency in the first half of 2019. In the U.S., AR101 has FDA Fast Track Designation, as well as FDA Breakthrough Therapy Designation for peanut-allergic patients ages 4-17

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