Aimmune Therapeutics Announces Clinical Collaboration to Study AR101 with Regeneron and Sanofi’s Dupilumab for Peanut Allergy
October 16 2017 - 7:30AM
Business Wire
— Phase 2 Clinical Trial Will Explore AR101
Treatment with Adjunctive Dupilumab in Peanut-Allergic Patients
—
— Trial Design Will Test Potential to Achieve
Sustained Unresponsiveness to Peanut Following Treatment —
— Conference Call Today at 8:30 a.m. Eastern
Time / 5:30 a.m. Pacific Time —
Aimmune Therapeutics, Inc. (NASDAQ:AIMT), a biopharmaceutical
company developing treatments for potentially life-threatening food
allergies, today announced a clinical collaboration with Regeneron
and its strategic alliance collaborator Sanofi to study AR101
treatment with adjunctive dupilumab in peanut-allergic patients in
a Phase 2 clinical trial. Regeneron will sponsor the trial, with
Aimmune to provide clinical supply of AR101 and food challenge
materials.
AR101 is Aimmune’s investigational biologic oral immunotherapy
for desensitization of patients with peanut allergy, and dupilumab
is a human monoclonal antibody that inhibits signaling of IL-4 and
IL-13 cytokines, which are believed to be major drivers of Type 2
inflammation.
“We are excited to work with Regeneron and Sanofi to explore the
potential of AR101 and dupilumab to increase both the degree of
protection and persistence of protection against exposure to peanut
protein,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “We have
worked diligently with regulatory authorities and have engineered a
manufacturing infrastructure that is purpose-built to meet strict
cGMP and quality standards, an essential component for conducting
rigorous studies such as this. Our Phase 2 findings showed AR101
was associated with both clinically meaningful levels of
desensitization and potential immunomodulatory effects on the
IgE-IgG4 ratio and peanut-specific TH2 cells. We look forward to
building on these findings and the upcoming readout of our pivotal
Phase 3 PALISADE trial through this clinical collaboration.”
“The incidence of food allergy continues to rise and with it the
risk of life-threatening allergic reactions,” said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of
Regeneron. “Dupilumab targets the IL-4/IL-13 signaling pathway,
which is a critical driver of allergic inflammation. In particular,
both preclinical and clinical studies suggest that dupilumab can be
a major regulator of the IgE-IgG4 axis. We look forward to
collaborating with Aimmune to evaluate if adjunctive treatment with
AR101 and dupilumab can help further protect people with peanut
allergies.”
The planned Phase 2 clinical trial is expected to begin in 2018.
It will explore desensitization with AR101 treatment with
adjunctive dupilumab (or placebo) in peanut-allergic patients, with
a proposed primary endpoint of tolerating a certain dose of peanut
protein in a double-blind, placebo-controlled food challenge
(DBPCFC) that will include doses matching and exceeding those being
tested in current AR101 studies. The study also includes a proposed
exploration of sustained unresponsiveness after discontinuation of
therapy in another DBPCFC. Sustained unresponsiveness is achieved
when, after a break in treatment, peanut-allergic patients are able
to tolerate a defined amount of peanut protein with no more than
mild allergic symptoms. This has been recently demonstrated with
low-dose oral immunotherapy in very young children.1
The clinical collaboration will include the formation of an
Aimmune–Regeneron/Sanofi Joint Development Committee.
“I am very intrigued by the concept of adding dupilumab to oral
immunotherapy (OIT) with AR101 for the treatment of peanut
allergy,” said James R. Baker, M.D., CEO of Food Allergy Research
and Education (FARE), the nation’s leading food allergy advocacy
organization. “I believe that this approach could provide important
insights into potential tolerability gains and increased durability
of treatment response in OIT. Any approach that could broaden the
eligible treatment population or support improved outcomes would be
enthusiastically welcomed by peanut-allergic patients and their
families.”
Dupilumab (marketed under the brand name DUPIXENT®) is being
jointly developed by Regeneron and Sanofi under a global
collaboration agreement. Potential uses beyond the indication
approved by the U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMA) are investigational, and no
regulatory authority has evaluated their safety and efficacy.
Conference Call and Webcast Information
Aimmune will host a conference call and live audio webcast
Monday, October 16, 2017, at 8:30 a.m. ET / 5:30 a.m. PT to discuss
the clinical collaboration and the planned study of AR101 treatment
with adjunctive dupilumab in peanut-allergic patients. The
conference call will be accessible via the company’s website at
www.aimmune.com on the Events page under Investor Relations. Please
connect to the company’s website at least 15 minutes prior to the
start of the conference call to ensure adequate time for any
software download that may be required to listen to the webcast.
Alternatively, participants may dial 1-877-497-1438 (domestic) or
1-262-558-6296 (international) and refer to conference ID 2521888.
An archived copy of the webcast will be available on the company’s
website for at least 30 days after the conference call.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., a clinical-stage biopharmaceutical
company, is developing treatments for life-threatening food
allergies. Aimmune’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.
Reference
1. BP Vickery et al. Early oral immunotherapy in peanut-allergic
preschool children is safe and highly effective. Journal of Allergy
and Clinical Immunology
http://dx.doi.org/10.1016/j.jaci.2016.05.027.
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,
including in combination with dupilumab; Aimmune’s expectations
regarding the anticipated timing of any future clinical trials,
including the Phase 2 clinical trial to be sponsored by Regeneron
and Sanofi; and 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; Aimmune’s or any of its
collaborative partners’ ability to initiate and/or complete
clinical trials; 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; Aimmune’s reliance on third
parties for the manufacture of Aimmune’s product candidates; and
possible regulatory developments in the United States and foreign
countries. 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 June 30, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171016005355/en/
Aimmune Therapeutics, Inc.Investors:Laura Hansen, Ph.D.,
650-396-3814lhansen@aimmune.comorMedia:Stephanie Yao,
650-351-6479syao@aimmune.com
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