– Full Results from Phase 3 ARTEMIS Study
Will Be Featured –
Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical
company developing treatments for life-threatening food allergies,
today announced that it will present AR101 and patient quality of
life data at the European Academy of Allergy and Clinical
Immunology (EAACI) 2019 Congress, taking place June 1 to 5, 2019,
in Lisbon, Portugal. Of the six abstracts accepted by EAACI, three
are oral presentations and one is a late-breaker poster
presentation.
“We are eager to present the full topline results from our Phase
3 ARTEMIS trial, which further support the evidence we first showed
with our PALISADE and RAMSES studies that AR101-treated patients
can expect to achieve a clinically meaningful level of
desensitization,” said Daniel Adelman, M.D., Chief Medical Officer
of Aimmune. “We believe that the positive results from our entire
AR101 Phase 3 program, which we also will be discussing during the
meeting, demonstrate that AR101 has a consistent benefit-risk
profile. In addition, we are also pleased to be presenting data
that underscore the real-world effects of living with peanut
allergy as reported by patients themselves.”
The data will be presented as follows:
Oral Presentations
Title: ARTEMIS: A European, Phase 3, Randomised,
Double-Blind, Placebo-Controlled Trial of AR101 In Peanut-Allergic
Children And Adolescents Aged 4-17 (abstract
OA0023)Presenter: Montserrat Fernandez-Rivas, M.D., Hospital
Clinico San Carlos, Madrid, SpainSession Title: Oral
Abstract Session 04: Outcome measures in allergen and
immunotherapyDate/Time: Sunday, June 2, 2019 / 11:32 a.m. to
11:44 a.m. (WEST) / 6:32 a.m. to 6:44 a.m. (ET)Location:
Hall 13 (FIL)
Title: Extended Daily Dosing of AR101 For Peanut Allergy
Results in Higher Tolerated Doses And Continued Immunomodulation
(abstract OA0120)Presenter: Katharina Blümchen, M.D.,
University Hospital Frankfurt, Frankfurt, GermanySession
Title: Oral Abstract Session 21: Treatment of food
allergyDate/Time: Tuesday, June 4, 2019 / 10:42 a.m. to
10:52 a.m. (WEST) / 5:42 a.m. to 5:52 a.m. (ET)Location:
Hall 8 (FIL Meeting Centre)
Title: Improvement in Disease-Specific Quality of Life
for Peanut-Allergic Subjects Receiving AR101 Maintenance Therapy
(abstract OA0166)Presenter: Jonathan Hourihane, M.D.,
University College Cork, Cork, IrelandSession Title: Oral
Abstract Session 28: Achieving tolerance and better quality of life
in food allergic patientsDate/Time: Tuesday, June 4, 2019 /
2:32 p.m. to 2:44 p.m. (WEST) / 9:42 a.m. to 9:44 a.m.
(ET)Location: Hall 13 (FIL)
Poster Presentations
Title: Allergy to Peanut ImPacting Emotions and Life
(APPEAL) 2: The First European Multi-Country Qualitative Evaluation
of the Impact of Living with Peanut Allergy. (late breaking poster
LBPD1761)Presenter: Audrey Dunn Galvin, Ph.D., University
College Cork, Core, IrelandSession Title: Late Breaking
Poster Discussion Sessions 04 Food Allergy: Cutting-edge
conceptsDate/Time: Monday, June 3, 2019 / 1:45 p.m. to 3:15
p.m. (WEST) / 8:45 a.m. to 10:15 a.m. (ET)Location: PDS Dome
in e-Poster Area D (FIL)
Title: Real-World Experience and Management of Peanut
Allergy: A Quantitative Study of Adolescents With Peanut Allergy In
The United States (e-poster PD0550)Presenter: Christine
Birchwood, Ph.D., Sr. Director, Interim head, Medical Affairs at
Aimmune TherapeuticsSession Title: Poster Discussion Session
26: Management of food allergyDate/Time: Tuesday, June 4,
2019 / 1:10 p.m. to 3:00 p.m. (WEST) / 8:10 a.m. to 10 a.m.
(ET)Location: PDS Dome in e-Poster Area (FIL)
Title: Baseline Demographics of >1100 Peanut-Allergic
Subjects Aged 4-17 Years Randomised in Three Double-blind
Placebo-controlled Phase 3 AR101 Trials: PALISADE, RAMSES and
ARTEMIS (e-poster PD0548)Presenter: Kirsten Beyer, M.D.,
Charité Universitātsmedizin Berlin, Berlin, GermanySession
Title: Poster Discussion Session 26: Management of food
allergyDate/Time: Tuesday, June 4, 2019 / 1:30 p.m. to 3:00
p.m. (WEST) / 8:30 a.m. to 10 a.m. (ET)Location: PDS Dome in
e-Poster Area (FIL)
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 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 frequency and severity of adverse events,
including anaphylaxis, following exposure to peanut. The BLA for
AR101 is under review by the U.S. FDA, which in 2015 granted AR101
Breakthrough Therapy Designation for the desensitization of
peanut-allergic patients 4 to 17 years of age. Aimmune expects to
file for marketing approval of AR101 in Europe in 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 in 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 presentation of AR101 data at the 2019 European Academy
of Allergy and Clinical Immunology Congress, including data from
the ARTEMIS trial and regarding patient quality of life; Aimmune’s
expectations regarding the potential benefits of AR101; Aimmune’s
expectations regarding the potential commercial launch of AR101,
including the 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 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; 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
Quarterly Report on Form 10-Q for the quarter ended March 31,
2019. 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, and AR201, a product candidate that
Aimmune expects will be under clinical investigation in 2019.
Neither AR101 nor AR201 has been approved for marketing by
the FDA or the European Medicines Agency (EMA).
AR101 and AR201 are currently limited to investigational use, and
no representation is made as to their safety or effectiveness for
the purposes for which they are being investigated.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190524005106/en/
Investors:Eric Bjerkholt(650) 376-5582
orebjerkholt@aimmune.comMedia:Jerica Pitts(312)
858-3469jpitts@w2ogroup.com
Aimmune Therapeutics (NASDAQ:AIMT)
Historical Stock Chart
From Apr 2024 to May 2024
Aimmune Therapeutics (NASDAQ:AIMT)
Historical Stock Chart
From May 2023 to May 2024