Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that it will host an Analyst and Investor Event on the evening of March 4, 2018, at the joint congress of the American Academy of Asthma, Allergy and Immunology (AAAAI) and the World Allergy Organization (WAO) in Orlando, Florida, following a late-breaking oral presentation of the company's Phase 3 PALISADE trial results earlier that afternoon.
The Analyst and Investor Event will bring together leading expert allergists to discuss the results of Aimmune's Phase 3 PALISADE trial of AR101 for the treatment of peanut allergy, which were announced by the company on February 20, 2018.
Additional PALISADE data will be presented at AAAAI-WAO, including analyses exploring the impact of baseline characteristics on patient outcomes, peanut-specific biomarkers (ps-IgE and ps-IgG4), and symptom severity during the double-blind, placebo-controlled food challenge.
Phase 3 PALISADE Late-Breaking Oral Presentation Details
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 Science
2:00 – 3:15 p.m. EST, Sunday, March 4, South Concourse, Level 1, South Hall A1
Analyst and Investor Event Details
A live webcast of the Analyst and Investor Event will start at approximately 6:30 p.m. EST on March 4, 2018, and may be accessed in the Investor Relations section of Aimmune's website at www.aimmune.com under the Events page. A replay will be available for at least 30 days. Analysts and investors who would like to attend the event in Orlando should RSVP to Laura Hansen at firstname.lastname@example.org for additional details.
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.
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: the potential impact of baseline characteristics of patients in the PALISADE phase 3 study on patient outcomes; Aimmune's expectations regarding the potential benefits of AR101; Aimmune's expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies; and Aimmune's expectations regarding the availability of additional AR101 data in March 2018 at AAAAI-WAO. 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 the results of early clinical trials may not be predictive of future results; 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 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 Annual Report on Form 10-K for the year ended December 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.