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.

AR101 is an investigational biologic oral immunotherapy designed to reduce the frequency and severity of allergic reactions in case they are accidentally exposed to peanut.

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.

Developmental Program

Phase 3 Clinical Trials

PALISADE (Peanut ALlergy Oral Immunotherapy Study of AR101 for DEsensitization in Children and Adults) is our core, pivotal Phase 3 clinical trial for AR101.

  • 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 (Real-World AR101 Market Supporting Experience Study in Peanut-Allergic Children) began enrolling participants ages 4-17 in the US and Canada in May 2017.

  • 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.

ARTEMIS (AR101 Trial in Europe Measuring Oral Immunotherapy Success).

  • ARTEMIS is designed to expand the data on the level of and speed to which participants being treated with AR101 become desensitized to peanuts.
  • Top-line results were announced in May 2018.

Phase 2 Clinical Trials

We have successfully completed our primary Phase 2 study (ARC001) and conducted a follow-on study (ARC002) of AR101 for peanut allergy. The results from our primary Phase 2 study have been published in The Journal of Allergy and Clinical Immunology: In Practice.1

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.