PALISADE trial of AR 101 for peanut allergy is published in NEJM. Aimmune Therapeutics.

Aimmune Therapeutics, Inc. announced that the New England Journal of Medicine (NEJM) has published the full results of the landmark phase III PALISADE clinical trial of AR 101 Aimmune�s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. PALISADE is the largest and first successful phase III peanut allergy immunotherapy trial to date.

As reported in the NEJM article, �AR 101 Oral Immunotherapy for Peanut Allergy,� PALISADE met its primary endpoint and key secondary endpoints. In the trial�s primary analysis of peanut-allergic children and adolescents ages 4�17, AR 101 treatment resulted in a significant increase in the amount of peanut protein tolerated, compared to placebo. The increase, which was measured through a series of doses in an exit food challenge, suggests that AR 101-treated patients could expect to have protection against reactions to accidental peanut exposures. In a real-world translation of the amounts of peanut protein tolerated (where one whole peanut kernel contains approximately 250�300 mg of peanut protein), 67% of AR 101 patients tolerated a single dose of at least 2 peanuts; among AR 101 patients who completed the trial, 85% percent tolerated this level, which is equivalent to 3�4 peanuts of total exposure. Also, 50% of AR 101 patients tolerated the highest challenge level, a single dose equivalent to 3�4 peanuts (7�8 peanuts total exposure).

AR 101 treatment also resulted in a reduction in the number and severity of reactions in the exit food challenge, compared to placebo. In the exit challenge, 10% of AR 101 patients received epinephrine, and the median dose at which it was given was 1,000 mg of peanut protein (or 2,043 mg of total exposure), compared to 53% of placebo patients at a median dose of 100 mg. This corresponds to an overall 81% reduction in epinephrine use in AR 101 patients across all levels of the exit challenge, with a 99% reduction at the 300-mg level and a 94% reduction at the 600-mg level.

AR 101 demonstrated a favorable safety profile in the highly atopic patient population enrolled in PALISADE. Treatment-emergent adverse events occurred in more than 95% of patients in both trial groups, and nearly all were mild or moderate in severity. In AR 101 patients who experienced treatment-related adverse events, 2.4% experienced severe adverse events and 1.1% experienced serious adverse events. Epinephrine was used for severe adverse events in two patients, one of which was the single case of anaphylaxis in the trial.

See- Vickery BP, Vereda A, Casale TB, et al." AR101 oral immunotherapy for peanut allergy" New Engl J Med 2018; DOI: 10.1056/NEJMoa1812856.