BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing desensitization treatments for food allergies, announced today that the results of ARC002, an open-label Phase 2 continuation trial of Aimmune’s lead investigational product, AR101 for the treatment of peanut allergy, will be presented at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Los Angeles.
Aimmune announced that AR101 demonstrated robust efficacy in ARC001, a Phase 2, double-blind, placebo-controlled trial in peanut-allergic patients ages 4-21, at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2015 in June. In ARC001, 100 percent of active-arm patients who completed the study’s up-dosing protocol (n=23) were desensitized to a cumulative amount of 443 mg of peanut protein, and 78 percent of active-arm patients who completed the study were desensitized to a cumulative amount of 1,043 mg of peanut protein (the highest amount challenged in the ARC001 exit double-blind, placebo-controlled food challenge). As a typical peanut kernel contains approximately 250-300 mg of peanut protein, the tolerated amounts reached in ARC001 well exceed the levels of an everyday accidental exposure to peanut, which would likely involve as little as a fraction of a peanut or as much as a single peanut.
Aimmune announced additional positive AR101 findings, from the ARC002 continuation trial, in November. In ARC002, which moved former placebo patients to active treatment and followed all patients through an additional 12-week maintenance period, a substantial number of patients were desensitized to a higher cumulative amount of 2,043 mg of peanut protein, and AR101’s favorable safety and tolerability profile was confirmed.
Dr. J. Andrew Bird, assistant professor at the University of Texas Southwestern Medical Center, will present comprehensive AR101 efficacy and safety data from ARC002 in a late-breaking oral abstract session at AAAAI (details below), in accordance with Aimmune’s policy of releasing data at scientific meetings.
“Since we announced positive findings from our ARC002 Phase 2 follow-on trial late last year, we’ve been eager to share our full dataset with everyone who is tracking our progress,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “We’re excited to see our data presented to leading food allergy researchers and practitioners at the prestigious AAAAI meeting and to have the opportunity to contribute to further understanding of the potential of peanut allergy desensitization.”
The efficacy of AR101, a peanut-derived pharmaceutical for oral
J. Andrew Bird, M.D., Assistant Professor, University of Texas
|Date:||Sunday, March 6, 2016|
|Time:||2:30-2:45 p.m. Pacific Standard Time|
Late-Breaking Oral Abstract Session: Clinical Translational
|Location:||Los Angeles Convention Center, Level One, Petree Hall D|
All abstracts for the 2016 AAAAI Annual Meeting are available at www.jacionline.org.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for peanut allergy and other food allergies. The company’s characterized oral desensitization immunotherapy (CODIT™) system, an approach to oral immunotherapy (OIT), uses rigorously characterized product candidates with gradual, controlled up-dosing protocols to obtain clinically meaningful desensitization to food allergens. Aimmune Therapeutics initiated the Phase 3 PALISADE trial of its lead product, AR101, a complex mixture of natural peanut proteins and pharmaceutical-grade ingredients for the treatment of peanut allergy, one of the most common food allergies, in early 2016. AR101 has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age. For more information, please see www.aimmune.com.