Peanut allergy is a common and serious immunological disorder characterized by high unmet medical need. AR101 is a novel, investigational oral biologic drug aiming to address this unmet need by reducing the risk of allergic reaction following accidental peanut exposures.
We conducted PALISADE, a Phase 3 randomized, double-blind, placebo-controlled trial of oral immunotherapy (OIT) with AR101 in peanut-allergic patients aged 4-55 in the United States, Canada, and Europe. Eligible subjects reacted at ≤ 100 mg of peanut protein during double-blind, placebo-controlled food challenge (DBPCFC) at screening. Subjects completed initial escalation and up-dosing phases, approximately six months of 300 mg/day maintenance treatment, and an exit DBPCFC.
844 subjects entered screening; 555 were randomized and 551 received ≥ 1 dose of study drug. The study population averaged 11.3 years of age (range 4-49), was 57% male, and 79% Caucasian. Atopic comorbidities were common. 406 (74%) had a history of peanut anaphylaxis prior to screening. Baseline median (IQR) values were as follows: peanut skin prick wheal diameter 11.5 (9-15) mm; peanut-specific IgE 58.9 (16.6-190) kUA/L; and entry reactive DBPCFC dose 30 (10-100) mg. At the time of this submission, 526 of 551 subjects have completed their participation in the study. Unblinded safety and efficacy data for all 551 subjects will be available for presentation at the 2018 AAAAI meeting.
Conclusions: The results of PALISADE, the first Phase 3 and largest OIT trial, will advance the field and provide critically needed data to determine the efficacy and safety of AR101 and better characterize peanut-allergic patients.