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
adulthood5,6,7,8 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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Investors: Aimmune Investor Relations (650) 614-5220
ir@aimmune.com
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jnormart@w2ogroup.com
Lauren Barbiero (646) 564-2156 lbarbiero@w2ogroup.com
Europe Media: Louise Strong +44 7747-477509
lstrong@w2ogroup.com
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