Exhibit 99.1
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Landmark PALISADE Trial of AR101 Published in
New England Journal of Medicine
— Treatment with AR101 significantly increased the amount of peanut protein tolerated and reduced the number and severity of reactions to peanut protein —
— Aimmune conference call Monday, November 19 at 8:00 a.m. Eastern —
BRISBANE, California, November 18, 2018— Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that theNew England Journal of Medicine (NEJM) has published the full results of the landmark phase 3 PALISADE clinical trial of AR101, Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. PALISADE is the largest and first successful phase 3 peanut allergy immunotherapy trial to date.
“This publication in theNew England Journal of Medicine recognizes the rigor, scale and importance of the PALISADE trial, which will inform ongoing research in food allergy and could change practice for peanut allergy,” said A. Wesley Burks, M.D., Executive Dean and Curnen Distinguished Professor of Pediatrics, University of North Carolina School of Medicine, member of the Aimmune Scientific Advisory Board, and senior author of theNEJM publication. “Peanut allergy demands lifelong vigilance to avoid accidental exposures, and the unpredictable severity of reactions that do occur can take a toll on children and families. By significantly reducing the frequency and severity of allergic reactions to peanut, AR101 could provide reassurance and make a meaningful, beneficial impact on people’s daily lives.”
As reported in theNEJM article, “AR101 Oral Immunotherapy for Peanut Allergy,”1 PALISADE met its primary endpoint and key secondary endpoints. In the trial’s primary analysis of peanut-allergic children and adolescents ages 4–17, AR101 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 AR101-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 AR101 patients tolerated a single dose of at least 2 peanuts; among AR101 patients who completed the trial, 85% percent tolerated this level, which is equivalent to 3–4 peanuts of total exposure. Also, 50% of AR101 patients tolerated the highest challenge level, a single dose equivalent to 3–4 peanuts (7–8 peanuts total exposure).