Aimmune Therapeutics announced that it has initiated Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, or POSEIDON, an international, Phase 3 clinical trial of AR101 in peanut-allergic children ages 1-3 years. AR101 is Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. The primary efficacy endpoint for POSEIDON is tolerating a 600-mg single dose of peanut protein (the equivalent of approximately two peanut kernels) with no more than mild symptoms in a progressive, exit, double-blind, placebo-controlled food challenge after approximately one year of treatment.
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