Type of information: Recruitment of the first patient
Announcement: recruitment of the first patient
Company: Aimmune Therapeutics (USA - CA) previously Allergen Research Corporation (ARC)
Action mechanism: immunotherapy product. AR101 is part of Aimmune Therapeutics’ approach to treating food allergies using its characterized oral desensitization immunotherapy, or CODIT™, system. The CODIT system leverages extensive independent scientific research on oral immunotherapy, or OIT, demonstrating that food allergy patients can be desensitized to exposure to food allergens by being administered well-defined, gradually increasing doses of the allergen over a period of months. Aimmune Therapeutics’ CODIT system is designed to precisely control the amount of allergen administered and follow a systematic dosing regimen that begins with very low doses of the allergen. Once a patient attains desensitization to a clinically meaningful level of food allergen, the patient continues to take a daily maintenance dose of the CODIT system product in order to maintain such desensitization.
Disease: peanut allergy
Therapeutic area: Allergic diseases
Trial details: ARTEMIS (ARC010) is a randomized, double-blind, placebo-controlled trial in peanut-allergic children and adolescents ages 4-17. The inclusion criteria for the trial will allow for baseline toleration of a cumulative amount not exceeding 144 mg of peanut protein in an entry DBPCFC (i.e., reacting at or before a cumulative amount of 444 mg of peanut protein, at the 300 mg dose of the challenge). Patients will undergo approximately six months of up-dosing and then three months of maintenance therapy at 300 mg of AR101 per day, followed by an exit DBPCFC. Aimmune expects ARTEMIS to enroll between 120 and 160 patients at multiple sites in Europe, beginning in mid-2017. (NCT03201003)