Press Releases

LONDON--(BUSINESS WIRE)--Aug. 24, 2020-- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that findings from APPEAL-2 (Allergy to Peanuts ImPacting Emotions And Life-2), the largest cross-sectional, pan-European, qualitative study to evaluate the psychosocial burden of living with peanut allergy, were published in Clinical & Experimental Allergy, the official journal of the British Society for Allergy & Clinical Immunology. The study highlights the substantial impact of peanut allergy (PA) on the lives of children, teenagers, and their caregivers. The study demonstrates how coping and management of PA are driven by fear of accidental exposure and reaction to peanut, and the resulting emotional, social, relationship, and work effects.

“In their own words, children, teens and their caregivers revealed the day-to-day difficulties of living with peanut allergy and how the lack of societal awareness impacts their emotional and social development, thereby suggesting a widespread need for improved quality of peanut allergy health management and education,” said Audrey DunnGalvin, Ph.D., an investigator on both the APPEAL-1 and APPEAL-2 projects and a lecturer in the School of Applied Psychology at University College Cork in Cork, Ireland. “These findings reinforce what we learned from the quantitative data generated from the APPEAL-1 study and provide further insight for clinicians and policymakers on the significant needs among these allergic individuals and their caregivers throughout Europe.”

APPEAL-2 was designed to further explore key areas of impact identified in the two-part APPEAL-1 study (Allergy. 2020;00:1-10.; Allergy. 2020;00:1-16) which found that individuals experience frustration, stress, uncertainty and low levels of confidence in managing their peanut allergy. The open access manuscript, entitled “APPEAL-2: a pan-European qualitative study to explore the burden of peanut-allergic children, teenagers, and their caregivers,” is published online and can be accessed through the following link: https://onlinelibrary.wiley.com/doi/10.1111/cea.13719.

“The results of APPEAL-2 reinforce the findings of APPEAL-1 and further underscore that peanut-allergic individuals are more likely to experience feeling different, isolated, and restricted from social activities than their peers; their caregivers more often experience stress and adverse impacts on work and career,” said Daniel Adelman, M.D., Chief Medical Officer at Aimmune. “Both peanut-allergic individuals and caregivers experience anxiety, worry, sadness, and annoyance, and reported their lives are adversely affected by peanut avoidance, accidental reactions to peanuts, and the fear of reacting to peanuts.”

Key Findings include:

Children and Teens

• Most teenagers reported negative experiences when going to restaurants with friends, including embarrassment at having to declare their PA or being treated unkindly by staff.
• Almost a third of children and a small number of teenagers did not want others to know about their PA and actively chose not to disclose it, some because of embarrassment, others to avoid teasing or bullying.
• Almost all children and teenagers reported a negative impact of PA on their social activities. For children and teens, using “avoidance” as a strategy of disease management included not only restaurants, but avoidance of certain places (e.g., school, cinemas) and missing activities with friends.
• Children and teenagers felt left out or envious due to being unable to attend social events and share food with others; several participants reported incidents of teasing and/or bullying.
• A quarter of teens reported an impact on dating and on boyfriend/girlfriend relationships.

Caregivers

• Over a third reported that their child’s PA had a negative impact on their work and/or career, including having to take time off and decreasing their working hours, demonstrating the potential socioeconomic impacts.
• For caregivers, buying and preparing food was a major, time-consuming aspect of managing their child’s PA.
• Caregivers often mentioned needing to determine suitable places to eat and the distance to a hospital or pharmacy beforehand.
• Almost a quarter of caregivers preferred to avoid social events if peanuts were served or if they would have no control over the environment.
• Some caregivers (parents) did not allow their children to attend social events, causing children to “miss out” on many social activities.
• Caregiver anxiety was rooted in a lack of control; approximately half reported worrying about having less control of their child’s food and environment as the child became more independent.

Results also uncovered opportunities to reduce the burden of living and coping with PA including: the importance of education to increase awareness and understanding of PA in both the general public and healthcare professionals across Europe; developing more clear and meaningful precautionary allergen food labeling, and; developing more informative communication around food allergen risk and safety.

Nederlands Anafylaxis Netwerk, The Anaphylaxis Campaign, Deutscher Allergie- und Asthmabund, Food Allergy Italia, Asociación Española de Personas con Alergia a Alimentos y Látex, Association Française pour la Prévention des Allergies, and Astma-Allergi Danmark contributed to the study design of the APPEAL Study.

About the APPEAL Studies

APPEAL-1 (Allergy to Peanuts ImPacting Emotions And Life 1) collected data from 1,846 participants in eight European countries and was the first pan-European quantitative, cross-sectional survey that explored the burden and psychosocial impact of living with PA with use of a novel questionnaire. Full results were published in Allergy in May 2020. APPEAL-2 (Allergy to Peanuts ImPacting Emotions And Life 2) collected data from 107 participants, including 24 children and 39 teenagers with peanut allergy, and 44 caregivers/parents in eight European countries and was the first qualitative evaluation of the influence of living with peanut allergy.

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, accounting for the majority of deaths related to food allergy.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. 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 and Aimmune’s expectations regarding the development and commercialization of treatments for 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 June 30, 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.

¹ EAACI. Food Allergy & Anaphylaxis Public Declaration, 2015. http://www.eaaci.org/attachments/FoodAllergy&AnaphylaxisPublicDeclarationCombined.pdf
² EAACI. Food Allergy & Anaphylaxis Public Declaration, 2015. http://www.eaaci.org/attachments/FoodAllergy&AnaphylaxisPublicDeclarationCombined.pdf
³ Du Toit G, et al. N Engl J Med 2015; 372: 803-13
⁴ Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-3.
⁵ Crespo JF, James JM, Fernandez-Rodriguez C, Rodriguez J. Food allergy: nuts and tree nuts. Br J Nutr. 2006; 96:Suppl 2:S95-S102.
⁶ Moreno MA. Guidelines for children with peanut allergy. JAMA Pediatr. 2017;171:100.
⁷ 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.
⁸ 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.
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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Source: Aimmune Therapeutics, Inc.