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.
Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that it will present data during a late-breaking oral abstract session and in poster sessions at the 2018 American Academy of Allergy, Asthma & Immunology-World Allergy Organization Joint Congress, taking place March 2-5 in Orlando. The Congress abstracts were posted online today at www.jacionline.org. The late-breaking oral abstract presentation will report data from Aimmune's pivotal PALISADE Phase 3 clinical trial (following the company's topline data announcement in February), which evaluated the efficacy and safety of AR101, Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy (Abstract L6). Additional abstracts will report on the methodology of the PALISADE follow-on trial, ARC004 (Abstract 772), and on current management of peanut allergy in the United States (Abstract 820). Presentation details are as follows: Oral L6: Jones S, et al., Efficacy and Safety of AR101 in Peanut Allergy: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial (PALISADE)3609: Late Breaking Oral Abstract Session: Clinical Science2:00 - 3:15 p.m. EST, Sunday, March 4, South Concourse, Level 2, S220B Poster #772: Prescott K, et al., Exploration of Non-Daily Maintenance Dosing Regimens in Peanut Oral Immunotherapy4208: Poster Session: Food Allergy Diagnosis and Treatment9:45 - 10:45 a.m. EST, Monday, March 5, South Concourse, Level 1, South Hall A2 Poster #820: Blaiss M, et al., Limitations in Current Peanut Oral Immunotherapy (POIT) Practices in the U.S.4208: Poster Session: Food Allergy Diagnosis and Treatment9:45 - 10:45 a.m. EST, Monday, March 5, South Concourse, Level 1, South Hall A2 An additional poster presentation will feature Aimmune-supported work: Poster #751: Kronfel C, et al., Epitope Mapping for the Non-Specific Lipid Transfer Proteins (nsLTP) Among Peanut Allergic Patients4208: Poster Session: Food Allergy Diagnosis and Treatment9:45 - 10:45 a.m. EST, Monday, March 5, South Concourse, Level 1, South Hall A2 About Aimmune Therapeutics Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for potentially 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. 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 availability of topline data from the PALISADE trial of AR101 in February 2018 and additional data in March 2018 at AAAAI-WAO; 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 possibility that Aimmune's clinical trials, including PALISADE, will not be successful; the possibility that the results of early clinical trials may not be predictive of future results; 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; and Aimmune's dependence on the success of AR101. 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 September 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.