Developing an orally administered biologic immunotherapy for the treatment of peanut allergy
Aimmune’s lead investigational drug, AR101 for peanut allergy, has been rigorously developed, tested, and clinically tested through Phase 3 clinical trials in the United States and Europe.
Through our investigational Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach—which builds on a century of oral immunotherapy research—gradually increasing doses of AR101 would desensitize patients to peanut over a period of about six months. Afterward, patients would continue to take maintenance doses of AR101 in order to maintain desensitization.
As an allergenic drug product designed for use as a peanut allergy treatment, AR101, upon regulatory approval, would meet the stringent manufacturing and quality requirements established by regulatory authorities. The Biologics License Application (BLA) for AR101 was accepted by the U.S. Food and Drug Administration (FDA) and is currently undergoing review. Additionally, Aimmune plans to submit a marketing authorization application (MAA) for AR101 to the European Medicines Agency (EMA) in mid-2019.
We have had more than 1,000 participants in our clinical trials for AR101 and continue to advance toward our objective of providing a regulatory-approved treatment for patients with peanut allergy while we continue to contribute to the scientific understanding of food allergy.
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 U.S., 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.
- ARTEMIS is designed to expand the data on the level of and speed to which participants being treated with AR101 become desensitized to peanut.
- Top-line results were announced in March 2019.
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
1. JA Bird 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. Journal of Allergy and Clinic al Immunology: In Practice.