Aimmune Therapeutics Completes Global Enrollment of Phase 3 PALISADE Trial of AR101 for the Treatment of Peanut Allergy
November 28 2016 - 8:01AM
Business Wire
— Top-Line PALISADE Data Expected in 4Q 2017
—
— New Clinical Study: ARTEMIS Dedicated
European Pediatric Trial of AR101 Will Explore Protection at an
Endpoint of Tolerating 2,043 mg of Peanut Protein after Nine Months
of Treatment —
Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical
company developing CODIT™ (Characterized Oral
Desensitization ImmunoTherapy) treatments for
life-threatening food allergies, today announced that it has
completed global enrollment of its Phase 3 PALISADE trial of AR101
for the treatment of peanut allergy, with the total randomized to
the trial expected to be approximately 540 patients. AR101 is
Aimmune’s investigational biologic oral immunotherapy for
desensitization of patients with peanut allergy.
Aimmune continues to expect topline data from PALISADE in the
fourth quarter of 2017, followed by regulatory submissions for
marketing approval of AR101 in 2018 in both the United States and
Europe. The company announced completion of North American
enrollment in PALISADE in September, ahead of schedule and above
target enrollment.
Aimmune also announced ARTEMIS (AR101 Trial in
Europe Measuring oral Immunotherapy
Success), a new dedicated European clinical trial of AR101
in peanut-allergic children and adolescents. ARTEMIS is designed to
expand the data available on the efficacy profile of AR101 by
exploring a higher level of protection after a shorter treatment
period in a broader group of patients (in terms of baseline
reaction) than in PALISADE. The primary efficacy endpoint in this
new trial will be tolerating a cumulative amount of 2,043 mg of
peanut protein in an exit double-blind, placebo-controlled food
challenge (DBPCFC) after approximately nine months of treatment
with AR101.
“PALISADE remains the cornerstone of our AR101 program, and the
completion of global enrollment is a significant milestone. Now
that the $145 million investment in Aimmune by Nestlé Health
Science has closed, we have additional resources to further
strengthen our development strategy,” said Aimmune CEO Stephen
Dilly, M.B.B.S., Ph.D. “As previously announced, the RAMSES study,
slated to begin in the United States in early 2017, is expected to
provide important experience of AR101 in a ‘real-life’ clinical
setting, building on our observation that removal of the baseline
food challenge may meaningfully improve the tolerability of the
early stages of AR101 treatment. We expect to file our biologics
license application (BLA) on successful completion of PALISADE and
RAMSES.
“With ARTEMIS, we are building on the observation that a very
high proportion of patients in our ARC002 trial were desensitized
to more than two grams of peanut protein at the nine-month
endpoint. ARTEMIS is designed to confirm that finding in a
double-blind, placebo-controlled setting,” said Dr. Dilly.
“Demonstrating reliable, early desensitization with AR101 to such
high levels would cement the utility of our low-dose, CODIT
maintenance regimen. Furthermore, tolerating more than two grams of
peanut protein would give patients an additional safety net in
cases of accidental exposure, well after the threshold where they
may taste peanut, which could offer greater reassurance and peace
of mind. We expect to include the ARTEMIS results in our initial
marketing authorization application in Europe.”
Sue Barrowcliffe, General Manager of Aimmune Europe, commented:
“In Europe, we have seen great demand across multiple countries to
be included in the global PALISADE trial, so we are very excited to
conduct ARTEMIS as a dedicated European trial. It will offer a
wider range of children and adolescents with peanut allergy the
opportunity to participate in our clinical development program, and
it will help to enhance our knowledge about the timing and extent
of desensitization offered by AR101 treatment. As we have engaged
with more stakeholders across Europe, we have also come to
appreciate that confirming a higher efficacy reached sooner would
be important in obtaining labeling for protection against
accidental exposure and supporting reimbursement applications for
AR101, especially as we see increased focus on cost effectiveness
throughout Europe.”
ARTEMIS is a randomized, double-blind, placebo-controlled trial
in peanut-allergic children and adolescents ages 4-17. The
inclusion criteria for the trial will allow for baseline toleration
of a cumulative amount not exceeding 144 mg of peanut protein in an
entry DBPCFC (i.e., reacting at or before a cumulative amount of
444 mg of peanut protein, at the 300 mg dose of the challenge).
Patients will undergo approximately six months of up-dosing and
then three months of maintenance therapy at 300 mg of AR101 per
day, followed by an exit DBPCFC. Aimmune expects ARTEMIS to enroll
between 120 and 160 patients at multiple sites in Europe, beginning
in mid-2017.
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 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 in ages 4-55. AR101 is a
characterized, regulated, oral biological drug product containing
the protein profile found in peanuts. 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 Phase 3 PALISADE trial of AR101,
including its expected size and timing of topline data; Aimmune’s
expectations regarding the potential benefits of AR101; Aimmune’s
expectations regarding the sufficiency of its capital resources;
Aimmune’s expectations for the RAMSES and ARTEMIS studies,
including the timing of the trials; Aimmune’s expectations on
regulatory submissions for marketing approval of AR101 in the
United States and Europe, including the timing of these
submissions; 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 Annual Report on Form 10-K for the year ended 2015
and Quarterly Report on Form 10-Q for the quarter ended September
30, 2016. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161128005311/en/
Aimmune Therapeutics, Inc.InvestorsLaura Hansen, Ph.D.,
650-396-3814lhansen@aimmune.comorMediaStephanie Yao,
650-351-6479syao@aimmune.com
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