Media contact: Mark Derewicz, 984-974-1915, email@example.com
November 19, 2018
CHAPEL HILL, NC – Aimmune Therapeutics, Inc., a California-based biopharmaceutical company developing treatments for potentially life-threatening food allergies, published in the New England Journal of Medicine its full results of the landmark phase 3 PALISADE clinical trial of AR101, an investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. PALISADE is the largest and first successful phase 3 peanut allergy immunotherapy trial to date.
“This paper recognizes the rigor, scale and importance of the PALISADE trial, which will inform ongoing research in food allergy and could change practice for peanut allergy,” said senior author A. Wesley Burks, MD, Executive Dean and Curnen Distinguished Professor of Pediatrics at the University of North Carolina School of Medicine, and member of the Aimmune Scientific Advisory Board. “Peanut allergy demands lifelong vigilance to avoid accidental exposures, and the unpredictable severity of reactions that do occur can take a toll on children and families. By significantly reducing the frequency and severity of allergic reactions to peanut, AR101 could provide reassurance and make a meaningful, beneficial impact on people’s daily lives.”
The PALISADE study met its primary endpoint and key secondary endpoints. In the trial’s primary analysis of peanut-allergic children and adolescents ages 4–17, AR101 treatment resulted in a significant increase in the amount of peanut protein tolerated, compared to placebo. The increase, which was measured through a series of doses in an exit food challenge, suggests that AR101-treated patients could expect to have protection against reactions to accidental peanut exposures.
People who are allergic to peanuts have a specific antibody as part of their immune systems that overreacts to the peanut protein, resulting in a variety of symptoms, such as hives, nausea, constricted airways, low blood pressure, and shock.
Oral immunotherapy offers patients a way to train their immune systems to not overreact. AR101 contains a precise dose of peanut protein. Patients in the clinical trial were initially given a tiny amount of peanut protein, about 1mg or less. For comparison, a peanut kernel contains about 300mg of peanut protein. Over the course of a year, patients steadily increased their consumption of peanut protein. By the end of one year, 67 percent of AR101 patients tolerated a single dose of at least 2 peanuts – 600mg. But that amount is much more the amount parents and patients fear in most accidental exposures. The main reason people with peanut allergies must never eat anything made in a facility where peanuts are also processed is because there’s a chance about 100mg or less of peanut dust found its way into a product that was not intended to contain peanuts.
While using AR101 as a therapy, avoidance of peanuts is still crucial. But if AR101is approved by the FDA, it would offer families further defense against severe allergic reactions.