Designed for Peanut Allergy Therapy
A first-of-its-kind, investigational, orally administered, biologic immunotherapy to reduce the frequency and severity of peanut allergy reactions in children and adolescents.
Patients ingest controlled, increasing amounts of AR101 over a period of about six months or longer. The result is that the patient’s immune system tolerates larger amount of peanut. After the dose escalation period, the patient continues to take a daily therapeutic dose to maintain desensitization.
Upon approval, our standardized treatment protocol will give allergists access to a medication that aims to provide predictable and reliable peanut allergy tolerance for their patients.
AR101 has been studied in clinical trials involving over 1,000 participants.
Phase 3 Clinical Trials
- PALISADE is the largest randomized clinical trial for peanut allergy to date, enrolling more than 550 participants ages 4-55 in the US, Canada, and Europe.
- This clinical trial was designed to evaluate the efficacy and safety of AR101 to treat peanut allergy.
- Top-line results were announced in February 2018.
- The results from PALISADE were published in the New England Journal of Medicine in November 2018.
- RAMSES is designed to gain experience with AR101 in a real-world setting, without the use of a “food challenge”—a diagnostic test conducted by a physician to confirm that an individual has a food allergy or has successfully been desensitized to a food allergen.
- This clinical trial is designed to evaluate the safety of AR101 to treat peanut allergy.
Phase 2 Clinical Trials
As an oral biologic immunotherapy designed for use as a peanut allergy treatment, AR101—upon approval—will meet the stringent manufacturing and quality requirements established by regulatory authorities.
The Biologics License Application (BLA) for AR101 was accepted by the US Food and Drug Administration (FDA) and is currently undergoing review. Additionally, Aimmune has submitted a marketing authorization application (MAA) for AR101 to the European Medicines Agency (EMA).
1. Bird JA, Spergel JM, Jones SM, et al. Efficacy and safety of AR101 in oral immunotherapy for peanut allergy: results of ARC001, a randomized, double-blind, placebo-controlled Phase 2 clinical trial. J Allergy Clin Immunol Pract. 2018;6(2):476-485.