An Aimmune Therapeutics Inc. allergy medication improved the tolerability of peanuts in children following nine months of treatment, meeting the main goal of a phase 3 European clinical trial.
The drug, AR101, is intended to reduce the risk of anaphylaxis — a potentially life-threatening allergic reaction that includes skin rash and difficulty in breathing — due to accidental exposure to peanuts.
Aimmune enrolled 175 children and adolescents ages 4 to 17 in the phase 3 trial known as Artemis. The participants took increasing doses of the drug during the first six months followed by a daily dose of 300 milligrams.
The proportion of patients in the treatment arm of the trial who saw their tolerability of peanut protein grow from 10 milligrams to 1,000 milligrams was significantly higher compared to the placebo group. No cases of anaphylaxis were observed during the trial.
Based on the results of this late-stage study, the Brisbane, Calif.-based biotechnology company plans to submit a marketing application for AR101 to the European Medicines Agency in midyear.
The U.S. Food and Drug Administration recently accepted Aimmune's biologics license application for the peanut allergy drug. According to Aimmune, the FDA's review of AR101 could take until January 2020.
The results from Artemis are similar to a previous phase 3 study in which 50.3% of the AR101-treated patients were able to tolerate 1,000 milligrams of peanut protein.