Aimmune Therapeutics Announces Presentation at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting

— Aimmune Late-Breaking Abstract Posted Online Today by The
Journal of Allergy and Clinical Immunology (JACI) —

— Dr. J. Andrew Bird Will Present Data on the Efficacy and Safety of
AR101 for the Treatment of Peanut Allergy from the ARC002 Phase 2
Follow-On Trial —

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.”

   
Title:

The efficacy of AR101, a peanut-derived pharmaceutical for oral
immunotherapy
(OIT), is maintained and tolerability is increased with low-
dose
maintenance therapy

 
Presenter:

J. Andrew Bird, M.D., Assistant Professor, University of Texas
Southwestern
Medical Center

 
Date: Sunday, March 6, 2016
 
Time: 2:30-2:45 p.m. Pacific Standard Time
 
Session:

Late-Breaking Oral Abstract Session: Clinical Translational
Sciences,
2:00-3:15 p.m. Pacific Standard Time

 
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.

Contacts

Investors
Stern Investor Relations
Beth DelGiacco, 212-362-1200
beth@sternir.com
or
Media
Edelman
Amanda
Breeding, 415-229-7649
amanda.breeding@edelman.com