Peanut Allergy Oral Desensitization Immunotherapy Successfully Met End-Points
PALISADE clinical trial of AR101 Meets Primary Endpoint in Patients With Peanut Allergy
Food allergies are a growing food safety and public health concern that affect an estimated 4%–6% of children in the United States, says the Centers for Disease Control and Prevention (CDC).
There is no cure for food allergies, and reactions to peanuts can be life-threatening. More than 170 foods have been reported to cause allergic reactions.
In the United States, peanut allergy has become the leading cause of anaphylaxis and death related to food allergy. The prevalence of peanut allergy is more than 2% of children in 2010.
A Phase 3 clinical trial named Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in children and adults (PALISADE) of AR101 reported it successfully met the primary endpoint.
This oral desensitization immunotherapy, AR101 has received Food and Drug Administration (FDA) Breakthrough Therapy Designation for peanut-allergic patients ages 4–17.
After approximately one year of treatment, patients completed an exit double-blind, placebo-controlled food challenge (DBPCFC).
In the primary analysis of 496 patients, ages 4–17, 67.2% of AR101 patients tolerated a single highest dose of at least 600 mg of peanut protein (1043 mg cumulative) with no more than mild symptoms in the exit DBPCFC, compared to 4.0% of placebo patients.
The corresponding difference in response rates was 63.2% (p<0.00001, 95% CI=53.0–73.3%), and, at 53%, the lower bound of the 95% confidence interval greatly exceeded the pre-specified success criterion, which was 15%.
Additionally, 50.3% of AR101 patients tolerated a single highest dose of 1000 mg of peanut protein (2043 mg cumulative), compared to 2.4% of placebo patients (p<0.00001).
In order to minimize the risk of assessment bias, the primary endpoint evaluations were conducted by independent, blinded assessors, who were not involved in patients’ ongoing care in the trial and who were blinded to treatment assignment and the sequence of the DBPCFCs.
“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, M.D., Executive Dean and Curnen Distinguished Professor of Pediatrics, University of North Carolina School of Medicine, and a principal investigator for PALISADE.
“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.”
“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.”
Aimmune expects to submit a Biologics License Application (BLA) for AR101 with the FDA by the end of 2018, followed by a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) in the first half of 2019.
No conflicts of interest were reported.
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