– Full Results from Phase 3 ARTEMIS Study Will Be Featured –
BRISBANE, Calif.–(BUSINESS WIRE)–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,
Spain
Session Title: Oral Abstract Session 04: Outcome
measures in allergen and immunotherapy
Date/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, Germany
Session Title: Oral
Abstract Session 21: Treatment of food allergy
Date/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, Ireland
Session Title: Oral Abstract
Session 28: Achieving tolerance and better quality of life in food
allergic patients
Date/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,
Ireland
Session Title: Late Breaking Poster Discussion
Sessions 04 Food Allergy: Cutting-edge concepts
Date/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
Therapeutics
Session Title: Poster Discussion Session 26:
Management of food allergy
Date/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,
Germany
Session Title: Poster Discussion Session 26:
Management of food allergy
Date/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.
Contacts
Investors:
Eric Bjerkholt
(650) 376-5582 or
ebjerkholt@aimmune.com
Media:
Jerica
Pitts
(312) 858-3469
jpitts@w2ogroup.com