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 to accidental peanut exposure.
The patient ingests controlled, increasing amounts of AR101 over a period of about 6 months. Over time, the patient’s immune system may become desensitized to peanut allergen and therefore able to tolerate exposure to larger amounts of peanut protein. After the dose escalation period ends, the patient continues to take a daily therapeutic dose to maintain desensitization.
If approved by the US Food and Drug Administration, our standardized treatment protocol will give allergists access to a medication that can provide predictable and reliable peanut allergy tolerance for their patients.

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 years 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.

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RAMSES (Real-World AR101 Market Supporting Experience Study in Peanut-Allergic Children) began enrolling participants ages 4-17 years 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.

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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.

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Developmental Program

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 US Food and Drug Administration (FDA) approval—will meet the stringent manufacturing and quality requirements established by regulatory authorities.

The Biologics License Application for AR101 was accepted by the FDA and is currently undergoing review. Additionally, Aimmune has submitted a marketing authorization application for AR101 to the European Medicines Agency.

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.