information: update on patient enrollment
Announcement: recruitment of the first patient
Company: Aimmune Therapeutics (USA - CA) previously Allergen Research Corporation (ARC)
- 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
area: Allergic diseases
- 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)
- • On January 8, 2018, Aimmune Therapeutics announced that the ARTEMIS (ARC010) trial is on track to complete enrollment in the first quarter of 2018, and Aimmune expects data from ARTEMIS in early 2019.
- • On July 5, 2017, Aimmune Therapeutics announced the enrollment of its first patient in the European Phase 3 ARTEMIS (ARC010) clinical trial of AR101 for treatment of peanut allergy. The randomized, double-blind, placebo-controlled ARTEMIS (AR101 Trial in Europe Measuring oral Immunotherapy Success) clinical trial of AR101 will enroll approximately 160 peanut-allergic children and adolescents ages 4-17 at multiple sites in several European countries. The ARTEMIS trial follows Aimmune’s ongoing Phase 3 PALISADE trial, taking place in eight countries in Europe, the United States, and Canada. Aimmune designed the ARTEMIS trial to expand the data on the level of and speed to clinically meaningful modulation of the immune response to AR101 treatment. The primary efficacy endpoint for ARTEMIS is tolerating a 1,000-mg single dose of peanut protein (the equivalent of approximately three to four peanut kernels) in a progressive, exit double-blind, placebo-controlled food challenge (DBPCFC) after approximately nine months of treatment.
- The enrollment criteria for ARTEMIS allow inclusion of peanut-allergic patients who react to 300 mg or less of peanut protein in an entry DBPCFC.
- • On November 28, 2016, Aimmune Therapeutics announced ARTEMIS (AR101 Trial in Europe Measuring oral Immunotherapy Success), a new dedicated European clinical trial of AR101 in peanut-allergic children and adolescents. ARTEMIS is designed to expand the data available on the efficacy profile of AR101 by exploring a higher level of protection after a shorter treatment period in a broader group of patients (in terms of baseline reaction) than in PALISADE. The primary efficacy endpoint in this new trial will be tolerating a cumulative amount of 2,043 mg of peanut protein in an exit double-blind, placebo-controlled food challenge (DBPCFC) after approximately nine months of treatment with AR101.