Aimmune Therapeutics, Inc., a biopharmaceutical company developing treatments for potentially life-threatening food allergies, announced this week that its phase 3 PALISADE efficacy trial of the AR101 immunotherapy treatment met the primary endpoint.
PALISADE enrolled 499 patients ages 4 to 17, 496 of whom received treatment. After approximately one year of treatment, patients completed an exit double-blind, placebo-controlled food challenge. About 67 percent of AR101 patients tolerated a single highest dose of at least 600 mg of peanut protein with no more than mild symptoms. Also, 50.3 percent of AR101 patients tolerated a single highest dose of 1000 mg of peanut protein.
“It’s exciting to see this large-scale study confirm that a characterized approach to oral immunotherapy, in an appropriately supervised clinical setting, holds promise for becoming an approved treatment,” said A. Wesley Burks, MD, Executive Dean and Curnen Distinguished Professor of Pediatrics at the UNC School of Medicine, and a principal investigator for PALISADE. “
It’s great to see patients who could tolerate just a tiny bit of peanut protein – at most, a tenth of a peanut – to now successfully eating the equivalent of two to four peanuts with nothing more than mild, transient symptoms, if any at all. Patients and their families are highly motivated to pursue an effective treatment for peanut allergy, and AR101 could give them a comfortable margin of safety in case of accidental exposures.”
Burks leads the UNC Food Allergy Institute, a team of researchers dedicated to finding new ways to help children and adults who suffer from food allergies.
Read more about the study at the Aimmune Therapeutics website.
University of North Carolina at Chapel Hill School of Medicine