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Aimmune Therapeutics Announces New Pan-European Study Showing Significant Psychosocial Burden Associated With Peanut Allergy

— European APPEAL (Allergy to Peanuts Impacting Emotions and Life) Study Finds Peanut Allergy Has a Daily Impact on More than 80% of People with Peanut Allergy and Parents or Caregivers of Peanut-Allergic Minors —

— Data Discussed at EAACI 2018 Reveal Uncertainty, Bullying and High Levels of Anxiety Around Food —

BRISBANE, Calif. & MUNICH--(BUSINESS WIRE)--May 30, 2018-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that data from a new study on the psychosocial burden of peanut allergy in European countries were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2018 in Munich.

The APPEAL (Allergy to Peanuts Impacting Emotions and Life) study is a multi-dimensional, multi-phase effort, led by Aimmune Therapeutics in partnership with an expert panel of European food allergy patient advocacy group leaders and healthcare professionals (psychologist, dietician and allergists), to learn about the psychosocial burden of peanut allergy. Audrey DunnGalvin, Ph.D., of University College Cork, Ireland, discussed the data in a late-breaking oral presentation.

In a quantitative online survey conducted in eight European countries, the APPEAL study examined the impact of peanut allergy on peanut-allergic children (as reported by a parent or caregiver), parents and caregivers of peanut-allergic children, and peanut-allergic adults. The survey results showed that peanut allergy has a daily impact on more than 80% of those children, parents/caregivers and adults, and 40% live with a high level of uncertainty. Additionally, 77% of peanut-allergic individuals have been made to feel different (negatively), and 43% have been affected by bullying.

The survey also revealed the increased level of anxiety people affected by peanut allergy experience in situations involving food. In food contexts, 60% of peanut-allergic children, 71% of parents and caregivers, and 56% of peanut-allergic adults experienced anxiety. In non-food contexts, 15% of peanut-allergic children, 11% of parents and caregivers, and 12% of peanut-allergic adults experienced peanut allergy–related anxiety.

“Peanut allergy, and the vigilance it requires around food, can impose a large psychosocial burden on affected individuals and families, but that burden can be invisible to others around them,” said Dr. DunnGalvin. “With APPEAL, we want to help bring that burden to light and understand how it is carried among different groups — peanut-allergic children, their parents and caregivers, and peanut-allergic adults. Our group of food allergy experts and advocates is committed to raising awareness of the impact of peanut allergy to increase support for improving care and treatments.”

Dr. DunnGalvin also discussed the methodology of the APPEAL study in an earlier poster presentation. The APPEAL survey was conducted in November 2017 in eight countries: Denmark, France, Germany, Ireland, Italy, the Netherlands, Spain, and the United Kingdom. It collected 1,846 responses from 546 peanut-allergic children (as reported by a parent or caregiver), 881 parents or caregivers, and 419 peanut-allergic adults.

“Aimmune is committed to learning from people’s experiences with food allergies and applying those insights to our efforts to develop approved therapeutics. The work and results of the APPEAL collaboration have been especially inspiring,” said Sue Barrowcliffe, General Manager of Aimmune Europe. “Many of the patient advocacy group leaders involved have first-hand experience with food allergy, and their insights on behalf of the community were a tremendous help in identifying key issues to query. We also benefited greatly from the expertise of the team’s healthcare professionals, who generously shared the knowledge they have amassed. Foremost, we are grateful to the many hundreds of people who responded to the survey so that we can better understand the challenges peanut-allergic individuals and their families face every day. We look forward to continuing to deepen that understanding.”

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for potentially life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4–17 years of age and is currently being evaluated in Phase 3 clinical trials. For more information, please see 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 the potential benefits of AR101; and 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 expectation that Aimmune will need additional funds to finance its operations; the company’s ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that the results of early clinical trials may not be predictive of future results; the possibility that Aimmune’s clinical trials will not be successful; Aimmune’s dependence on the success of AR101; the company’s reliance on third parties for the manufacture of the company’s 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, 2018. 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 a product that is under clinical investigation and that has not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). It 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.

Source: Aimmune Therapeutics, Inc.

Aimmune Therapeutics, Inc.
Investors
Laura Hansen, Ph.D., 650-396-3814
lhansen@aimmune.com
or
Media
Stephanie Yao, 650-351-6479
syao@aimmune.com