Last week, Aimmune Therapeutics – a clinical-stage biopharmaceutical company – announced they had enrolled their first participant in a second Phase III clinical trial of their AR101 peanut therapy. The trial, designated RAMSES, 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 first confirm peanut allergy. It will assess the safety and tolerability of AR101 versus placebo.
AR101 is the company’s peanut allergy therapy intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. The therapy received the Food and Drug Administration’s “Breakthrough Therapy Designation” which helps accelerate drug development.
RAMSES will enroll 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.
RAMSES joins the firm’s other AR101 Phase III trial designated PALISADES, currently underway. PALISADES first challenged participants with a food challenge to peanut before progressing to the therapy stage. As stated above, one of the goals of the RAMSES trial is to determine whether the peanut exposure due to the initial PALISADES food challenge is detrimental to the success of AR101 therapy.