— Trial Will Augment Ongoing Phase 3 PALISADE Trial and Explore
Endpoint of Tolerating at Least 1000-mg Dose of Peanut Protein to
Support AR101 Regulatory Filings in Europe —
BRISBANE, Calif.--(BUSINESS WIRE)--Jul. 5, 2017--
Aimmune Therapeutics, Inc. (Nasdaq:AIMT), today announced the enrollment
of its first patient in the European Phase 3 ARTEMIS (ARC010) clinical
trial of AR101 for treatment of peanut allergy. AR101 is Aimmune’s
investigational biologic oral immunotherapy for desensitization of
patients with peanut allergy.
The randomized, double-blind, placebo-controlled ARTEMIS (AR101 Trial
in Europe Measuring oral Immunotherapy Success)
clinical trial of AR101 will enroll approximately 160 peanut-allergic
children and adolescents ages 4-17 at multiple sites in several European
countries. The ARTEMIS trial follows Aimmune’s ongoing Phase 3 PALISADE
trial, taking place in eight countries in Europe, the United States, and
Canada.
“We have seen great interest from peanut-allergic patients and their
families in becoming participants in the Aimmune clinical trials,” said
Prof. George du Toit, M.B., B.Ch., Professor of Paediatric Allergy at
King's College London, Guy's and St Thomas' Trust. “Participants and
their families are keen to potentially benefit from an investigational
treatment in a disease area where there are currently no approved
products, and are motivated to contribute to developing our
understanding of peanut allergy and its treatment. We are all excited by
the momentum in the field and the potential impact a new treatment could
have on the burden of peanut allergy, which in many countries affects up
to 2 percent of children.” Professor du Toit is an investigator for the
PALISADE and ARTEMIS trials, currently underway at the Evelina
Children's Hospital, Guy’s and St. Thomas’ NHS Foundation Trust in
London.
Aimmune designed the ARTEMIS trial to expand the data on the level of
and speed to clinically meaningful modulation of the immune response to
AR101 treatment. The primary efficacy endpoint for ARTEMIS is tolerating
a 1,000-mg single dose of peanut protein (the equivalent of
approximately three to four peanut kernels) in a progressive, exit
double-blind, placebo-controlled food challenge (DBPCFC) after
approximately nine months of treatment.
“Desensitization to a threshold of at least 1,000 mg of peanut protein
would protect peanut-allergic patients from severe reactions following
an inadvertent bite of a peanut-containing food. Achieving high levels
of protection quickly and reliably is important to patients,” said Sue
Barrowcliffe, General Manager of Aimmune Europe. “In a Phase 2 study of
AR101 conducted in the United States, the majority of patients met the
endpoint we have set for ARTEMIS, after nine months of treatment. We
hope to confirm these findings with a larger patient population in
ARTEMIS, which along with PALISADE will provide the key efficacy and
safety data to support our potential initial marketing authorization
application for AR101 in Europe.”
The enrollment criteria for ARTEMIS allow inclusion of peanut-allergic
patients who react to 300 mg or less of peanut protein in an entry
DBPCFC. For more information about the ARTEMIS trial, please see: https://clinicaltrials.gov/show/NCT03201003.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical
company developing treatments for life-threatening food allergies. The
company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™)
approach is intended to achieve meaningful levels of protection by
desensitizing patients with defined, precise amounts of key allergens.
Aimmune’s first investigational biologic product using CODIT™, AR101 for
the treatment of peanut allergy, has received the FDA’s Breakthrough
Therapy Designation for the desensitization of peanut-allergic patients
4-17 years of age and is currently being evaluated in Phase 3 clinical
trials. 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 for its ARTEMIS
clinical trial of AR101, including the size of the trial and the
anticipated benefits from the primary efficacy endpoint; Aimmune’s
expectation that its PALISADE and ARTEMIS trials will provide the
primary efficacy and safety data for a potential marketing authorization
application for AR101 in Europe; Aimmune’s expectations regarding the
potential benefits of AR101; 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
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; Aimmune’s
dependence on the success of AR101; the company’s reliance on third
parties for the manufacture of the company’s product candidates;
possible 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, including its Quarterly Report on
Form 10-Q for the quarter ended March 31, 2017. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170705005293/en/
Source: Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc.
Investors
Laura Hansen, Ph.D.,
650-396-3814
lhansen@aimmune.com
or
Media
Stephanie
Yao, 650-351-6479
syao@aimmune.com
