Aimmune Therapeutics Receives EMA Decision Agreeing With PIP for AR101 for the Treatment of Peanut Allergy

BRISBANE, Calif.–(BUSINESS WIRE)–Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company
developing desensitization treatments for food allergies, today
announced that it has received the European Medicines Agency (EMA)
decision endorsing the company’s pediatric investigation plan, or PIP,
for AR101 for the treatment of peanut allergy. The decision follows the
EMA Paediatric Committee (PDCO) positive opinion on the PIP on August
14, 2015.

In Europe, an approved PIP is a required component of the EMA regulatory
approval process. A marketing authorisation application (MAA) can be
accepted only if the sponsor has an approved PIP and has completed the
relevant studies outlined in that plan.

“This positive opinion on our PIP puts us another step closer to having
a treatment to desensitize patients with peanut allergy and keep them
safe from dangerous reactions upon accidental exposure,” said Aimmune
CEO Stephen Dilly, M.B.B.S., Ph.D.. “With more than a million children
in Europe living with peanut allergy, we are dedicated to bringing them
a treatment that can give them and their families a significant level of
protection and peace of mind in their daily lives.”

In June, Aimmune announced that the results of its ARC001 Phase 2 trial
of AR101 for the treatment of peanut allergy demonstrated efficacy and
overall safety in peanut-allergic patients (ages 4-21). In that study,
100 percent of the 23 active-arm patients who completed the study met
the primary endpoint of tolerating exposure to 443 mg cumulative amounts
of peanut protein, and 78 percent met an additional endpoint of
tolerating exposure to 1,043 mg cumulative amounts of peanut protein.

The approved PIP includes Aimmune’s planned Phase 3 trial of AR101 for
the treatment of peanut allergy, expected to commence in early 2016.
This randomized, double-blind, placebo-controlled trial will enroll
approximately 500 peanut-allergic children, adolescents and adults (ages
4-55) in the United States and Europe. The PIP also includes an
additional randomized, double-blind, placebo-controlled study designed
to potentially allow expansion of the age range for AR101 treatment down
to one-year-old children. This additional study does not need to be
completed prior to potential approval of AR101.

About AR101 and CODIT™

Aimmune Therapeutics is developing AR101 as a potential desensitization
therapy for patients with peanut allergy to provide them with protection
from peanut allergens at a level believed to substantially exceed the
amount typically encountered in an accidental exposure. AR101 is a
complex mixture of naturally occurring proteins and pharmaceutical-grade
inactive ingredients designed to enable the convenient dosing of
consistent amounts of peanut protein with well-defined concentrations of
peanut allergens. Patients ingest AR101 mixed into small amounts of
palatable, age-appropriate foods.

AR101 is part of Aimmune’s approach to treating food allergies using its
characterized oral desensitization immunotherapy, or CODIT™, system. The
CODIT system leverages extensive independent scientific research on oral
immunotherapy, or OIT, demonstrating that food allergy patients can be
desensitized to food allergens by being administered well-defined,
gradually increasing doses of the allergen over a period of months.
Aimmune’s CODIT system is designed to precisely control the amounts of
the allergens administered in a systematic dosing regimen, beginning
with very low doses of the allergens. Once a patient attains
desensitization to a clinically meaningful level, the patient continues
to take a daily maintenance dose of the CODIT system product in order to
maintain the desensitization.

About Food Allergies

Food allergies are a significant and growing health problem in the
United States, Europe and throughout the developed world. It is
estimated that more than 30 million people in the United States and
Europe have a food allergy, and more than five million people in the
United States and Europe have peanut allergy, including more than two
million children. The prevalence of peanut allergy in children in the
United States is estimated to have increased at a constant annual growth
rate of approximately 10 percent between 1997 and 2008, and experts
believe it has continued to rise since 2008. For people living with food
allergies, certain foods can cause severe allergic reactions, including
potentially life-threatening anaphylaxis. There are no approved medical
therapies to cure food allergies or prevent their effects. Currently,
food-allergic patients manage their condition by strict allergen
avoidance and carrying epinephrine auto-injectors for use in case of
accidental exposure. Thus, in addition to the unmet medical need, food
allergies can impose a significant quality of life burden. For more
information, please see www.foodallergy.org
and www.niaid.nih.gov/topics/foodallergy.

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., founded in 2011 as Allergen Research
Corporation (ARC), is a clinical-stage biopharmaceutical company
developing treatments for peanut allergy and other food allergies.
Aimmune’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 recently completed a Phase 2 study of its lead
product, AR101, a complex mixture of naturally occurring proteins and
pharmaceutical-grade ingredients for the treatment of peanut allergy,
one of the most common food allergies. For more information, please see www.aimmune.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are
not historical facts are “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited
to, statements regarding: the timing and size of Aimmune’s planned Phase
3 trial; Aimmune’s expectations regarding the potential benefits of
AR101; and Aimmune’s expectations regarding the potential applications
of the CODIT™ system. Risks that contribute to the uncertain nature of
the forward-looking statements include: the expectation that Aimmune
will need additional funds to finance its operations; the company’s
ability to initiate and/or complete clinical trials; the
unpredictability of the regulatory process; the possibility that
Aimmune’s clinical trials will not be successful; reliance on third
parties for the manufacture of the company’s product candidates;
regulatory developments in the United States and foreign countries; and
the company’s ability to attract and retain senior management personnel.
These and other risks and uncertainties are described more fully in
Aimmune’s most recent filings with the Securities and Exchange
Commission (SEC), including the prospectus relating to the initial
public offering dated August 5, 2015, and the Quarterly Report on Form
10-Q for the second quarter of 2015 dated August 31, 2015. All
forward-looking statements contained in this press release speak only as
of the date on which they were made. Aimmune undertakes no obligation to
update such statements to reflect events that occur or circumstances
that exist after the date on which they were made.

This press release concerns a product that is under clinical
investigation and that has not yet been approved for marketing by the
U.S. Food and Drug Administration (FDA) or the European Medicines Agency
(EMA). It is currently limited to investigational use, and no
representation is made as to its safety or effectiveness for the
purposes for which it is being investigated.

Contacts

Investors:
Aimmune Therapeutics, Inc.
Amy Figueroa,
650-352-1039
investorrelations@aimmune.com
or
Media:
Edelman
Amanda
Breeding, 415-229-7649
amanda.breeding@edelman.com