Clinical Trials

Date: 2017-05-11

Type of information: Recruitment of the first patient

phase: 3

Announcement: recruitment of the first patient

Company: Aimmune Therapeutics (USA - CA) previously Allergen Research Corporation (ARC)

Product: AR101

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

Country: Canada, USA

Trial details:

The Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Age 4-17 Years, or RAMSES (ARC007) is a randomized, double-blind, placebo-controlled trial that will monitor treatment-emergent adverse events during a six-month up-dosing period. Patients will then be followed in an open-label manner for at least six months on the maintenance dose of 300 mg of AR101 per day. The trial is designed to gain experience with AR101 in a real-world setting, without the use of a double-blind, placebo-controlled food challenge (DBPCFC) to confirm peanut allergy. It will assess the safety and tolerability of AR101 versus placebo. (NCT03126227)

Latest news:

• On May 11, 2017, Aimmune Therapeutics announced the enrollment of its first patient in the Phase 3 RAMSES (ARC007) clinical trial of AR101 for treatment of peanut allergy. The trial follows the same up-dosing and maintenance protocol as Aimmune’s ongoing Phase 3 PALISADE trial, taking place in the United States, Canada, and eight countries in Europe.
RAMSES (ARC007) is enrolling approximately 440 peanut-allergic patients ages 4–17 at multiple sites in the United States and Canada. Patient selection is based on stringent entry criteria, including a well-documented medical history of IgE-mediated reactions to peanut (including anaphylaxis), skin reactivity, and analyses of peanut-specific allergic antibodies. The trial will monitor treatment-emergent adverse events during a six-month up-dosing period, and then, after unblinding, follow patients for at least six months on the maintenance dose of 300 mg of AR101 per day. Aimmune anticipates that the absence of an entry food challenge may improve the tolerability profile of AR101 in early stages of dosing by removing exposure to high levels of peanut allergen that may otherwise prime the immune system prior to treatment.
• On February 16, 2017, Aimmune Therapeutics provided an update on ongoing AR101 phase 3 program for peanut allergy based on FDA feedback. The company plans to initiate the RAMSES trial, which will enroll approximately 440 patients ages 4-17 in the United States, in 2Q 2017.