Aimmune Therapeutics Enrolls First Patient in RAMSES (ARC007), a Phase 3 Clinical Trial of AR101 for the Treatment of Peanut ...
May 11 2017 - 8:00AM
Business Wire
— “Real-World” Trial Will Augment Ongoing Phase
3 PALISADE Trial to Support Regulatory Filings and Market
Understanding —
Aimmune Therapeutics, Inc. (Nasdaq:AIMT), today announced the
enrollment of its first patient in the Phase 3 RAMSES (ARC007)
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 Real-World AR101
Market-Supporting Experience Study in
Peanut-Allergic Children Age 4-17 Years, or RAMSES (ARC007), trial
is designed to gain experience with AR101 in a real-world setting,
without the use of a double-blind, placebo-controlled food
challenge (DBPCFC) to confirm peanut allergy. It will assess the
safety and tolerability of AR101 versus placebo. The trial follows
the same up-dosing and maintenance protocol as Aimmune’s ongoing
Phase 3 PALISADE trial, taking place in the United States, Canada,
and eight countries in Europe.
“The peanut-allergic patients in my practice have been highly
motivated to participate in Aimmune’s clinical trials. They’re
looking for access to a potential treatment, since peanut allergy
patients are at risk for life-threatening anaphylaxis and have to
take extra caution with eating. My patients have been happy to have
the opportunity to participate in these clinical trials and help
with the effort which may lead to an approved product to treat
their problem,” said Stanley M. Fineman, M.D., Atlanta Asthma &
Allergy. “Not requiring the diagnostic food challenge requirement
is more consistent with the way we practice, where the diagnosis of
peanut allergy is typically made based on a strong clinical history
and corroborating positive skin prick tests and/or elevated blood
levels of peanut antibodies.”
RAMSES (ARC007) is a randomized, double-blind,
placebo-controlled trial enrolling approximately 440
peanut-allergic patients ages 4–17 at multiple sites in the United
States and Canada. Patient selection is based on stringent entry
criteria, including a well-documented medical history of
IgE-mediated reactions to peanut (including anaphylaxis), skin
reactivity, and analyses of peanut-specific allergic
antibodies.
The trial will monitor treatment-emergent adverse events during
a six-month up-dosing period, and then, after unblinding, follow
patients for at least six months on the maintenance dose of 300 mg
of AR101 per day. Aimmune anticipates that the absence of an entry
food challenge may improve the tolerability profile of AR101 in
early stages of dosing by removing exposure to high levels of
peanut allergen that may otherwise prime the immune system prior to
treatment.
“We’re conducting our RAMSES trial not only to support
regulatory filings and real-world market understanding, but also to
test whether removing the entry food challenge can lead to improved
tolerability of AR101 during early up-dosing. Recent data from our
collaborator Dr. Erik Wambre and his colleagues at the Benaroya
Research Institute on PALISADE patient samples support the idea
that the food challenge may activate the immune system and thus
increase the risk of additional allergic reactions in the early
up-dosing period that follows,” said Aimmune CMO, Daniel Adelman,
M.D. “Also, while some studies1,2 have shown that food allergy
patients and caregivers report improvements in quality of life
following food challenges, regardless of outcome, the process can
be emotionally tough. We’ve been hearing a lot of enthusiasm from
our PALISADE sites about starting RAMSES, and many of them have
waitlisted patients who are eager to participate in the trial.”
For more information about the RAMSES (ARC007) trial, please
see:
https://clinicaltrials.gov/ct2/show/NCT03126227
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.
References
1. Franxman TJ, Howe L, Teich E, Greenhawt MJ. Oral food
challenge and food allergy quality of life in caregivers of
children with food allergy. Journal of Allergy and Clinical
Immunology: In Practice 2015; 3:50.
2. van der Velde, J.L., Flokstra-de Blok, B.M., de Groot, H.,
Oude-Elberink, J.N., Kerkhof, M., Duiverman, E.J. et al, Food
allergy-related quality of life after double-blind,
placebo-controlled food challenges in adults, adolescents, and
children. Journal of Allergy and Clinical Immunology 2012;
130:1136–1143.e2.
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 RAMSES clinical trial of AR101,
including the expectation that the absence of a food challenge in
the trial may improve the tolerability of AR101; 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170511005453/en/
Aimmune Therapeutics, Inc.InvestorsLaura Hansen, Ph.D.,
650-396-3814lhansen@aimmune.comorMediaStephanie Yao,
650-351-6479syao@aimmune.com
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