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Results of Aimmune’s Pivotal Phase 3 European Trial of PALFORZIA® Published in The Lancet Child & Adolescent Health

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July 21, 2020

Peanut-Allergic Patients Treated with PALFORZIA Showed Desensitization to Peanut Protein with a Predictable Safety Profile at Nine Months

Clinically Meaningful Improvements in Food Allergy Quality of Life Were Reported in all Age Groups

BRISBANE, Calif.–(BUSINESS WIRE)–Jul. 21, 2020– 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.

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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.”

The manuscript, entitled “Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial,” is published online and can be accessed through the following link: https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(20)30234-0/fulltext

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Key findings include:

  • PALFORZIA-treated participants who tolerated a single 1,000 mg peanut protein dose (2,043 mg cumulative, equivalent to approximately seven peanut kernels) in the double-blind, placebo-controlled food challenge (DBPCFC) after nine months of treatment was significantly higher than in the placebo group (intention-to-treat: 58% vs. 2%; p<0.0001).
  • In the intention-to-treat analysis, 68% and 74% participants treated with PALFORZIA tolerated the 600 mg and 300 mg exit DBPCFC doses, respectively, compared with 9% and 16%, respectively, of placebo-treated participants (p<0.0001 for both comparisons).
  • The safety profile of PALFORZIA was consistent with previous PALFORZIA studies with the frequency and severity of allergic reactions as expected for an oral desensitization therapy. Over 98% of patients in both treatment arms experienced at least one adverse event. Adverse events most frequently affected the gastrointestinal tract, respiratory system, and skin, as has been observed in other peanut OIT trials. No severe systemic allergic reactions or cases of eosinophilic esophagitis were reported. In addition, use of epinephrine in the PALFORZIA arm was less that of the PALISADE phase 3 trial, potentially reflecting cultural differences in the use of epinephrine between the U.S. and Europe. Specifically, epinephrine/adrenaline use was reported in 7% of AR101 treated participants versus 2% of placebo, all for mild/moderate reactions and lower than reported in PALISADE. The PALFORZIA-treated participants were significantly less likely to develop severe symptoms at any challenge dose during the exit peanut DBPCFC, compared with these placebo-treated participants.
  • PALFORZIA-treated participants (self-reporting for ages 8-12, 13-17) and their caregivers (proxy reporting for children 4-17 years) recorded greater improvements in quality-of-life measures compared to the placebo group, as assessed via the Food Allergy Quality- of-Life Questionnaires (FAQLQs) and the Food Allergy Independent Measure (FAIM).

PALFORZIA was approved by the U.S. Food and Drug Administration (FDA) in January 2020 as an oral immunotherapy for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy.

PALFORZIA is not approved in Europe, where Aimmune’s marketing authorization application for AR101 is under review with the European Medicines Agency (EMA). The Swiss Agency for Therapeutic Products (SwissMedic) review of AR101 also is ongoing.

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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.

INDICATION

In the USA, PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older.

PALFORZIA is to be used in conjunction with a peanut-avoidant diet.

Limitations of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

IMPORTANT SAFETY INFORMATION

Boxed WARNING:

PALFORZIA can cause anaphylaxis, which may be life threatening and can occur at any time during PALFORZIA therapy.

Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.

Do not administer PALFORZIA to patients with uncontrolled asthma.

Dose modifications may be necessary following an anaphylactic reaction.

Observe patients during and after administration of the Initial Dose Escalation and the first dose of each Up-Dosing level, for at least 60 minutes.

PALFORZIA is available only through a restricted program called the PALFORZIA REMS.

CONTRAINDICATIONS

PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease.

WARNINGS AND PRECAUTIONS

Anaphylaxis

PALFORZIA can cause anaphylaxis, which may be life threatening. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA.

Anaphylaxis has been reported during all phases of PALFORZIA dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures.

Do not initiate PALFORZIA treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. PALFORZIA may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including but not limited to markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, PALFORZIA may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine.

All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered in a certified health care setting.

Patients may be more likely to experience allergic reactions following PALFORZIA administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (e.g., viral infection), or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding PALFORZIA temporarily.

Asthma

Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of PALFORZIA.

PALFORZIA should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of PALFORZIA should be undertaken cautiously. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of PALFORZIA.

Eosinophilic Gastrointestinal Disease

Discontinue PALFORZIA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain.

Gastrointestinal Adverse Reactions

Gastrointestinal adverse reactions were commonly reported in PALFORZIA-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms consider a diagnosis of eosinophilic esophagitis.

ADVERSE REACTIONS

The most common adverse events reported in subjects treated with PALFORZIA (incidence ≥ 5% and ≥ 5% than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide at www.PALFORZIA.com.

For more information about PALFORZIA, please call 1-844-PALFORZ (1-844-725-3679) or visit www.PALFORZIA.com.

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. For more information, please visit 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 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.

PALFORZIA®, AIMMUNE®, AIMMUNE THERAPEUTICS® and CODIT™ are trademarks of Aimmune Therapeutics, Inc.

References

EAACI. Food Allergy & Anaphylaxis Public Declaration, 2015.
http://www.eaaci.org/attachments/FoodAllergy&AnaphylaxisPublicDeclarationCombined.pdf
EAACI. Food Allergy & Anaphylaxis Public Declaration, 2015.
http://www.eaaci.org/attachments/FoodAllergy&AnaphylaxisPublicDeclarationCombined.pdf
Du Toit G, et al. N Engl J Med 2015; 372: 803-13
Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-3.
Crespo JF, James JM, Fernandez-Rodriguez C, Rodriguez J. Food allergy: nuts and tree nuts. Br J Nutr. 2006; 96:Suppl 2:S95-S102.
Moreno MA. Guidelines for children with peanut allergy. JAMA Pediatr. 2017;171:100.
Skolnick HS, Conover-Walker MK, Koerner CB, Sampson HA, Burks W, Wood RA. The natural history of peanut allergy. J Allergy Clin Immunol. 2001;107:367-74.
Fleischer DM, Conover-Walker MK, Christie L, Burks AW, Wood RA. The natural progression of peanut allergy: resolution and the possibility of recurrence. J Allergy Clin Immunol. 2003;112:183-9.
Yu W, Freeland DMH, Nadeau KC. Food allergy: immune mechanisms, diagnosis and immunotherapy. Nat Rev Immunol. 2016;16:751-65.
10 Boyce JA, Assa’ad A, Burks AW, et al. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol.
2010;126:Suppl:S1-S58.
11 Sampson HA, Aceves S, Bock SA, et al. Food allergy: a practice parameter update — 2014. J Allergy Clin Immunol. 2014;134(5):1016-25.e43.
12 Muraro A, Werfel T, Hoffmann-Sommergruber K, et al. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy. 2014;69:1008-25.
13 Rimbaud L, Heraud F, La Vieille S, Leblanc J-C, Crépet A. Quantitative risk assessment relating to the inadvertent presence of peanut allergens in various food product. Int Food Risk Anal J. 2013;3:1-11.
14 Allen KJ, Remington BC, Baumert JL, et al. Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications. J Allergy Clin Immunol. 2014;133:156-64.

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