Aimmune Therapeutics has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its lead investigational product, AR101, as oral immunotherapy for children aged four to 17 years with peanut allergies.
AR101 is part of firm’s approach to treat food allergies using its characterized oral desensitisation immunotherapy (CODIT) system.
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The company has designed CODIT system to precisely control the amount of allergen administered and follow a systematic dosing regimen that begins with very low doses of the allergen.
Aimmune Therapeutics CEO Dr Stephen Dilly said: "Currently, there are no approved medical therapies to treat the more than two million children and adolescents in the US and Europe with peanut allergy who are vulnerable to reactions from accidental exposures."
Approval was granted based on firm’s recently announced positive results of ARC001 from the Phase II study.
The trial is a randomised, double-blind and placebo-controlled study for desensitisation treatment of peanut allergy.
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By GlobalDataUnder the study, the company used ARC001 to treat 55 patients, including 29 in the active group and 26 in the placebo, while 54 were within a four to 17 age range, of the 55 patients.
In the trial, all patients who completed the active treatment regimen tolerated exposure to a cumulative amount of at least 443mg of peanut protein and 78% of those patients tolerated exposure to a cumulative amount of 1,043mg of peanut protein, said Aimmune.
In September 2014, FDA also granted fast track designation for AR101, prior to Phase II clinical data.
The company intends to start a Phase III confirmatory registration trial of AR101 for the desensitisation treatment of peanut allergy in children and adults.
