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Largest European Quantitative Study on Peanut Allergy Confirms Significant Need, Burden and Psychosocial Impact of Peanut Allergy on Allergic Individuals and their Caregivers

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-- Study highlights need to address varying levels of effective disease management, and the associated feelings of uncertainty, stress and isolation across eight European countries –

-- Country-specific data show German respondents experience highest levels of anxiety, more than half of UK respondents report being bullied, and feelings of isolation are most common among French respondents –

Aimmune Therapeutics, Inc. (NASDAQ:AIMT), a biopharmaceutical company developing and commercializing treatments for life-threatening food allergies, today announced that findings from APPEAL-1 (Allergy to Peanuts ImPacting Emotions And Life-1), a multi-dimensional pan-European study assessing the psychosocial effect and impact of living with peanut allergy, were published in Allergy, one of the official journals of European Academy of Allergy and Clinical Immunology (EAACI). The study, published in two parts (Part A and Part B), highlights the substantial impact peanut allergy has on every aspect of allergic individuals' and their caregivers' lives, including the uncertainty they feel around how to manage frightening and debilitating reactions and concerns about the feasibility of ongoing avoidance.

Peanut allergy is one of the most common food allergies, which affect over 17 million people in Europe.i 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.ii,iii Reactions to peanut are potentially life-threatening, accounting for the majority of deaths related to food allergy.iv

APPEAL-1 is the first and largest quantitative study to validate and bring attention to the significant burden and psychosocial impact with which allergic individuals and their caregivers are challenged in their daily lives. The findings illustrate the impact of living with the condition, and how attempting to avoid peanuts every day can be a major source of stress, fear and anxiety, clouded by the persistent worry of accidental exposure for both the allergic individual and their caregiver. The data also demonstrate that across Europe there is insufficient education for coping and living with the disease and the management of reactions. Ambiguity over how to use rescue medicine and the potential trauma of necessitating its use is an additional burden that people with peanut allergy currently face.

"Our findings show that those living with peanut allergy face many uncertainties and restrictions on their daily activities, in addition to constant feelings of frustration, anxiety, stress, isolation, and uncertainty in their everyday lives," said Audrey DunnGalvin, Ph.D., a lead investigator on the APPEAL-1 study and a lecturer in the School of Applied Psychology at University College Cork in, Ireland. "The findings also reveal the disparity across European countries and an urgent need for greater support, improved management, and education for both peanut-allergic people and the general public to help improve living with and managing peanut allergy."

The APPEAL-1 Part A data provide meaningful insights into the experience of those with peanut allergy related to their reactions and disease management. Of the 1,300 survey participants:

- 45% rate their worst allergy reactions as severe, and 31% require the use of rescue medicine (adrenaline auto-injector; AAI) and hospitalization for their worst reaction. Of this latter group, percentages are higher in younger age groups; 35% in children and 42% in teenagers, compared with 26% in adults.

- Despite this, more than a quarter had never been prescribed an adrenaline auto-injector (AAI), and only 24% of all respondents received training on what to do in an emergency. Of those that had been prescribed an AAI, only a third had received training on how to use it.

- 87.4% report multiple symptoms during their worst allergic reactions, the most common symptoms included swelling (lips, eyes, tongue), breathing difficulties/wheezing and itching mouth or throat tightness. Almost one third report gastrointestinal symptoms (vomiting 30%, nausea 27%, stomach pain/cramps 24%).

- Comorbidities are common, with 42%, 50% and 79% reporting comorbid allergic rhinitis, asthma, and other food allergy, respectively.

- Nearly half of all respondents (n=1,846) (46%) describe living with the disease as "more" or "much more" expensive than living without the disease, pointing to a financial burden associated with managing peanut allergy. Most respondents note "significant" indirect costs associated with the extra time needed for planning day-to-day activities (85%) and special events (91%).

The APPEAL-1 Part B data show the impact on individuals' freedom of choice in daily activities; feelings and emotions; impacts of bullying, and their ability to cope with peanut allergy. Of the 1,846 survey respondents:

- 90% report feeling frustrated and stressed, with over a third having frequent feelings of anxiety.

- 65% report feelings of isolation and 43% report experiencing bullying.

- 89% report feeling restricted on where to eat out and 84% feel limited on buying food.

- Moreover, respondents report limitations in other areas of their lives not related to food, such as choice of schools (55%), socializing (75%) and going to special occasions (89%). More than half (54%) even worry about exposure during social occasions where food is not involved.

Within these data, there are some cross-country differences observed:

- In Germany, the highest rates of anxiety are reported (52%), nearly a third (29%) said they had coped "not at all well" with peanut allergy at first diagnosis and nearly all respondents report restrictions in socializing and holidays (90% and 86% respectively).

- In France, nearly all respondents state they are made to feel "different" in a negative way (86%) and 74% report feelings of isolation.

- More than half (52%) of respondents in the UK report being bullied about their peanut allergy.

- Confidence in recognizing allergic reaction symptoms and on how and when to use rescue medicine was dangerously low in Germany and France. In Germany, only 22% feel "extremely confident" in recognizing allergic reaction symptoms, and only 12% know when to use rescue medicine. In France, only 14% of respondents report knowing how to use it.

"The study provides essential insight and data on peanut allergy comorbidities, severity of reactions, management, and suggests a widespread need in Europe for improved quality of peanut allergy health management and education", said Daniel Adelman, Chief Medical Officer of Aimmune. "These findings represent the largest quantitative data set to date and, importantly, deepen our knowledge and understanding of the impact of peanut allergy on everyday lives, further providing some signposts for clinicians and policymakers on significant needs among these patients that need to be addressed."

Aimmune has a Marketing Authorization Application (MAA) under review with the European Medicines Agency (EMA) for AR101, its investigational medicine for peanut allergy.

About the APPEAL-1 Study

APPEAL-1 (Allergy to Peanuts ImPacting Emotions And Life-1) collected data from 1,846 respondents (allergic individuals and their caregivers) across eight European countries and is the first pan-European quantitative, cross-sectional survey that explored the psychosocial impacts of living with peanut allergy with use of a novel questionnaire. The three respondent groups included 528 self-reporting adults with peanut allergy; 881 self-reporting caregivers, and 437 children with peanut allergy reported by proxy of their caregiver (of these children, 34 were aged 0-3 years, 287 aged 4-12 years, 116 aged 13-17 years).

About Peanut Allergy

Peanut allergy is one of the most common food allergies, which affects over 17 million people in Europe.v 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.vi,vii Reactions to peanut are potentially life-threatening, accounting for the majority of deaths related to food allergy.viii Peanut allergy usually persists into adulthoodix,x,xi,xii and there currently are no approved treatment options in Europe.xiii 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.xiv,xv,xvi Despite vigilance, accidental exposures may occurxvii and cause reactions of unpredictable severity,xviii leading to a lifelong risk of severe reactions.

About Aimmune Therapeutics

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, a marketing authorization application under review with the European Medicines Agency (EMA) for its investigational 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 commercialization; 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.

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

References

i EAACI. Food Allergy & Anaphylaxis Public Declaration, 2015. http://www.eaaci.org/attachments/FoodAllergy&AnaphylaxisPublicDeclarationCombined.pdf

ii EAACI. Food Allergy & Anaphylaxis Public Declaration, 2015. http://www.eaaciorg/attachments/FoodAllergy&AnaphylaxisPublicDeclarationCombined.pdf

iii Du Toit G, et al. N Engl J Med 2015; 372: 803-13

iv Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-3.

v EAACI. Food Allergy & Anaphylaxis Public Declaration, 2015. http://www.eaaci.org/attachments/FoodAllergy&AnaphylaxisPublicDeclarationCombined.pdf

vi EAACI. Food Allergy & Anaphylaxis Public Declaration, 2015. http://www.eaaci.org/attachments/FoodAllergy&AnaphylaxisPublicDeclarationCombined.pdf

vii Du Toit G, et al. N Engl J Med 2015; 372: 803-13

viii Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-3.

ix Crespo JF, James JM, Fernandez-Rodriguez C, Rodriguez J. Food allergy: nuts and tree nuts. Br J Nutr. 2006; 96:Suppl 2:S95-S102.

x Moreno MA. Guidelines for children with peanut allergy. JAMA Pediatr. 2017;171:100.

xi 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.

xii 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.

xiii Yu W, Freeland DMH, Nadeau KC. Food allergy: immune mechanisms, diagnosis and immunotherapy. Nat Rev Immunol. 2016;16:751-65.

xiv 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.

xv 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.

xvi 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.

xvii 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.

xviii 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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