Developing an orally administered biologic immunotherapy for the treatment of peanut allergy

Our lead product candidate, AR101, is a characterized, regulated, oral biological drug product containing the protein profile found in peanuts.

AR101
We have successfully completed Phase 2 studies of AR101 for the treatment of peanut allergy and are currently enrolling patients for our Phase 3 PALISADE (Peanut ALlergy Oral Immunotherapy Study of AR101 for DEsensitization in Children and Adults) trial.

  • International, randomized 3:1, double-blind, placebo-controlled, Phase 3 trial of the efficacy and safety of AR101 in a characterized desensitization (CODIT™) approach in patients with peanut allergy
  • Approximately 550 peanut-allergic patients 4-55 years of age
  • More than 60 clinical sites in the United States, Canada, and eight countries in Europe

The U.S. Food and Drug Administration (FDA) granted AR101 Fast Track Designation status, followed by Breakthrough Therapy Designation status, for its potential to treat a serious condition and fill an unmet medical need. If our planned Phase 3 studies for AR101 are successful, we anticipate filing a Biologic License Application, or BLA, with the FDA and a Marketing Authorization Application, or MAA, with the European Medicines Agency, or EMA.

We are developing AR101 and our CODIT™ approach with the objective of giving allergists a means of providing OIT treatment to their patients with peanut allergies.

We are developing AR101 to enable the convenient dosing of consistent amounts of peanut protein with well-defined concentrations of peanut allergens. If approved, it will be available in a range of accurately quantified dosages from 0.5 milligrams up to 300 milligrams to support our CODIT™ approach, from initiation to maintenance.

As used in our clinical trial, our CODIT approach for the treatment of peanut allergy supports an up-dosing desensitization regimen over an approximately 20-week period. The initial patient assessment and all up-dosings are scheduled to take place every two weeks at an allergist’s office, with steady-level daily home dosing in between visits. Following completion of the up-dosing protocol, patients continue to take an ongoing, daily maintenance dose of AR101 at a set amount.

Both at the physician’s office and at home, patients ingest their daily dose of AR101 mixed with a matrix food such as applesauce, pudding, yogurt or mashed potatoes.

Potential Impact

Potential Impact

We estimate that approximately six million people in the United States and Europe have peanut allergy, including more than two million children. Based on a 2014 study published in the Journal of Allergy and Clinical Immunology, we estimate that 40-50 percent of those people are sensitive to exposure to 100 milligrams or less of peanut protein. A typical peanut kernel contains approximately 250-300 milligrams of peanut protein.

Current Phase 3 PALISADE Trial

We are currently enrolling patients for PALISADE.

  • International, randomized 3:1, double-blind, placebo-controlled, Phase 3 trial of the efficacy and safety of AR101 in a characterized desensitization (CODIT™) approach in patients with peanut allergy
  • Approximately 500 peanut-allergic patients 4-55 years of age
  • 60 clinical sites in the United States, Canada, and nine countries in the European Union

Completed Phase 2 Clinical Trial of AR101

We have successfully completed our primary Phase 2 study NCT01987817 and conducted a follow-on study NCT02198664.

  • Randomized, double-blind, placebo-controlled trial of AR101 for the treatment of peanut allergy
  • Fifty-five patients with confirmed peanut allergy ranging in age from 4 to 21 years old
  • Eight sites at leading academic medical research centers in the United States