Brisbane, Calif.-based Aimmune Therapeutics Inc. said its peanut allergy drug met its primary goal in a late-stage study.
The company was evaluating AR101 in a phase 3 trial known as Palisade, which enrolled 499 patients ages 4 to 17, 496 of whom received treatment.
After one year, 67.2% of the patients who received AR101 were able to tolerate at least 600 milligrams of peanut protein, compared to 4% for placebo.
Further, 50.3% of the AR101-treated patients tolerated at least 1,000 milligrams of peanut protein, versus 2.4% of the placebo patients.
"It's great to have patients go from managing to tolerate at most the amount of peanut protein in a tenth of a peanut without reacting to successfully eating the equivalent of between two to four peanuts with nothing more than mild, transient symptoms, if any at all," the study's principal investigator, A. Wesley Burks, said in a statement.
Aimmune plans to submit a biologics license application for the drug with the U.S. Food and Drug Administration by the end of 2018, and a similar application with the European Medicines Agency in the first half of 2019.
AR101 uses trace amounts of peanut protein to slowly build up and maintain a base level of peanut tolerance in the most severely affected patients.
The company expects the drug to cost $5,000 to $10,000 for the first six months of dosing in which the patient becomes acclimated to the peanut protein and needs allergist monitoring. Following the six-month period, the drug is going to be priced $300 to $400 a month for daily maintenance doses.