BRISBANE - Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that complete results from its pivotal phase 3 European ARTEMIS trial (AR101 Trial in Europe Measuring Oral Immunotherapy Success) of PALFORZIA [Peanut (Arachis hypogaea) Allergen Powder-dnfp] have been published in The Lancet Child & Adolescent Health.
ARTEMIS met all primary, secondary and safety endpoints, and demonstrated that participants treated with PALFORZIA (known as AR101 outside of the United States) experienced a high degree of desensitization to peanut with an increasingly well-understood, anticipated, and manageable safety profile over nine months. Additionally, improvements in quality-of-life measures in PALFORZIA-treated participants were reported, most notably in how treatment affected the perceived likelihood of future accidental exposure and risk of severe reactions.
ARTEMIS is the third of three randomized, double-blind, placebo-controlled phase 3 trials within the PALFORZIA development program. The three trials comprise the largest clinical dataset in children and teens with peanut allergy and are the only phase 3 clinical trials to meet their primary endpoints.
'The results from ARTEMIS demonstrated that more than half of patients treated with PALFORZIA were able to tolerate the equivalent of approximately seven peanuts after only nine months of treatment and exhibited a safety profile consistent that seen in with our previously reported PALISADE trial. Additionally, there were clear improvements in self- and caregiver proxy-reported quality-of-life measures,' said Daniel Adelman, M.D., Chief Medical Officer of Aimmune Therapeutics. 'The publication of this data set, which is included in our marketing authorization application in Europe, underscores our commitment to transparency and to contributing toward the collective understanding of advancing the field of food allergy worldwide.'
About the ARTEMIS Study
ARTEMIS (AR101 Trial in Europe Measuring Oral Immunotherapy Success) evaluated the efficacy and safety of AR101 in 175 peanut-allergic participants aged 4 to 17 years who were enrolled at 18 sites in seven European countries (France, Germany, Ireland, Italy, Spain, Sweden and the United Kingdom). Study participants represented a highly allergic population with a high prevalence of comorbidities who reacted to low doses of peanut protein at screening DBPCFC. The primary endpoint was the patient's ability to tolerate at least a 1,000 mg single dose of peanut protein (2,043 mg cumulative, equivalent to approximately seven peanut kernels) without dose-limiting symptoms when given the DBPCFC.
About Peanut Allergy
Peanut allergy is one of the most common food allergies, which affects over 17 million people in Europe.1 The prevalence of peanut allergy in Europe has doubled between 2005 and 2015, and around two-thirds of schools in Europe currently have at least one child at risk of anaphylaxis.2,3 Reactions to peanut are potentially life-threatening, and account for the majority of food allergy-related deaths.4 Peanut allergy usually persists into adulthood 5,6,7,8 and there currently are no approved treatment options in Europe.9 The standard of care has been a strict elimination diet and the timely administration of rescue medications in case of an allergic reaction from accidental exposure.10,11,12 Despite vigilance, accidental exposures may occur13 and cause reactions of unpredictable severity,14 leading to a lifelong risk of severe reactions.
About Aimmune
Aimmune Therapeutics, Inc. is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies. With a mission to improve the lives of people with food allergies, Aimmune is developing and commercializing oral treatments for potentially 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 accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies.
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 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 risk that the COVID-19 worldwide pandemic may continue to negatively impact the business, research and clinical operations of Aimmune or its partners; 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 PALFORZIA; Aimmune's reliance on third parties for the manufacture of Aimmune's products and 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. 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 PALFORZIA, which has been approved for marketing by the FDA in the United States and has not been approved for marketing by the EMA or Swissmedic. PALFORZIA in Europe 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.
Contact:
Tel: (650) 614-5220
Email: ir@aimmune.com
AIMMUNE THERAPEUTICS, INC. 
