— If Approved, AR101 Will Be the First Medicine for This
Life-Threatening Condition —
BRISBANE, Calif.–(BUSINESS WIRE)–Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company
developing treatments for life-threatening food allergies, today
announced that the Biologics License Application (BLA) for AR101 has
been accepted for review by the U.S. Food and Drug Administration (FDA).
“Today is a significant milestone for Aimmune. The FDA’s acceptance of
our BLA is a crucial step forward in delivering AR101 to children, teens
and families living with the serious, daily risk of allergic reactions
to accidental exposure to peanuts,” said Jayson Dallas, M.D., President
and Chief Executive Officer of Aimmune. “We are working with the FDA to
complete their review as expeditiously as possible given that there are
currently no approved medicines for peanut allergy.”
Aimmune is developing AR101 as a treatment to reduce the risk of
anaphylaxis following accidental exposure to peanut. The FDA granted
AR101 Breakthrough Therapy Designation in June 2015 for peanut-allergic
children and adolescents ages 4-17, which was preceded by the granting
of Fast Track Designation in September 2014. Both of these programs
support expedited review of new drugs and biologics.
The FDA has informed Aimmune that the BLA will be reviewed under a
twelve-month target review period, as measured from the January 2019
start date. As a consequence, review of the BLA may take until late
January 2020. Aimmune is currently engaged in discussions with the FDA
regarding the review timeline for the AR101 BLA. The FDA expects to
convene an advisory committee meeting to discuss the application.
“Every day in the United States, more than one million children and
teens with peanut allergy are at risk that exposure to food allergens
could lead to potentially life-threatening reactions,” said Daniel
Adelman, M.D., Chief Medical Officer of Aimmune. “Published
epidemiologic studies and everyday experiences of this community show
that for many, avoidance of peanuts is not enough. There is an urgent
need for a rigorously developed, clinically proven medicine like AR101
that can help protect people when accidental exposures do occur.”
Aimmune’s BLA is comprised of extensive clinical as well as chemistry,
manufacturing and controls (CMC) data. Specifically, data from the
pivotal phase 3 PALISADE trial of AR101, the largest and only successful
phase 3 trial in peanut allergy, were published in the New England
Journal of Medicine and demonstrated that AR101 treatment
resulted in a significant increase in the amount of peanut protein
tolerated compared to placebo. The data suggest that AR101-treated
patients could expect fewer and less severe reactions to accidental
peanut exposures. Data from the phase 3 RAMSES trial confirmed the
safety profile of AR101 first observed in the PALISADE study; both
trials are part of the application submission.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a biopharmaceutical company developing
oral treatments for life-threatening food allergies. The company’s Characterized
Oral Desensitization
ImmunoTherapy
(CODIT™) approach is intended to provide meaningful levels of protection
against allergic reactions resulting from accidental exposure to food
allergens by desensitizing patients with defined, precise amounts of key
allergens. Aimmune’s first investigational biologic product, AR101 is
being developed as a treatment to reduce the risk of anaphylaxis
following accidental exposures to peanut. AR101 has received the FDA’s
Breakthrough Therapy Designation for the desensitization of
peanut-allergic patients 4-17 years of age. Aimmune expects to file for
marketing approval of AR101 in Europe mid-2019. Aimmune has filed an IND
application for its second product, AR201, for the treatment of egg
allergy and intends to start a randomized Phase 2 clinical trial
mid-2019. 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: Aimmune’s expectations regarding the potential
benefits of AR101; Aimmune’s expectations regarding the applicable
review period of the BLA for AR101; Aimmune’s expectations regarding the
planned timing and filing for marketing approval of AR101 in Europe;
Aimmune’s expectations on the timing of initiating a Phase 2 clinical
trial for AR201; and Aimmune’s expectations regarding potential
applications of the CODIT™ approach to treating life-threatening food
allergies. Risks and uncertainties that contribute to the uncertain
nature of the forward-looking statements include: the unpredictability
of the regulatory process; the possibility that Aimmune’s or any of its
collaborative partners’ clinical trials will not be successful;
Aimmune’s dependence on the success of AR101; possible regulatory
developments in the United States and foreign countries; and Aimmune’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, including
its Annual Report on Form 10-K for the year ended December 31, 2018. 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 AR101, a product candidate that is under
clinical investigation. AR101 has not been approved for marketing by the
FDA or the European Medicines Agency (EMA). AR101 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:
Eric Bjerkholt
(650) 376-5582 or
ebjerkholt@aimmune.com
Media:
Alison Marquiss
(650) 376-5583 or
amarquiss@aimmune.com