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A new oral biologic drug could reduce the risk of allergic reaction in children and adolescents following accidental peanut exposures, research has shown.
Researchers conducted PALISADE, a Phase 3 randomized, double-blind, placebo-controlled trial of oral immunotherapy (OIT) with AR101 in peanut-allergic patients aged 4 to 55 in Europe, the United States, and Canada.
Eligible subjects reacted at a challenge dose of 100mg or less of peanut protein (approximately one third of a peanut kernel) during a double-blind, placebo-controlled food challenge (DBPCFC) at screening.
The study looked at the proportion of participants aged four to 17 years of age who could ingest a challenge dose of 600 mg or more, without dose-limiting symptoms.
Study participants completed initial escalation and up-dosing phases, approximately six months of 300 mg per day maintenance treatment, and then an exit DBPCFC.
None of nearly 500 four to 17-year-olds taking part in the study could tolerate even a tenth of a peanut dose.
But after a year of taking small daily doses, 67% were able to ingest a dose of 600 mg or more of peanut protein, without dose-limiting symptoms, at the exit food challenge, researchers found.
However, no significant effect was found in participants 18 to 55 years of age.