Food Allergies - A Growing Problem

More than 30 million people in the US and Europe currently live with food allergies.1-4 And that number continues to grow. In the U.S., a food allergy sends someone to the emergency room every 3 minutes,5 and food allergies cost about $4 billion per year in direct medical expenses.6

Life-threatening Reactions

While more than 170 foods have been reported to cause allergic reactions, 8 major food allergens are responsible for most of the serious food allergy reactions in the US7:
  • Peanuts
  • Eggs
  • Tree nuts
  • Milk
  • Wheat
  • Soy
  • Fish
  • Crustacean shellfish
When exposed to a trigger food, allergic individuals can experience reactions ranging from mild to severe:
  • Mild—transient skin hives, tingling around the mouth, and gastrointestinal discomfort
  • Moderate—persistent hives, wheezing, abdominal discomfort, and increased vomiting
  • Severe—labored breathing and transient low blood pressure, which may require medical intervention and possibly hospitalization
In some cases, the allergic reaction can be life-threatening. Deaths, while rare, do occur.

Focus Areas

Peanut allergy is one of the most common food allergies, affecting more than 6 million people in the US and Europe. It can be a lifelong condition that 8 in 10 children with peanut allergy will never outgrow.
Egg allergy mainly affects children ages 1 to 4 years and is the most common food allergy in China and Japan. Nearly 6 million people in the US, China, Japan, the UK, Spain, Germany, France, and Italy are allergic to eggs.

Characterized Oral Desensitization Immunotherapy (CODIT™) – A Unique Platform

We are using an approach to food allergy treatment that works through the body’s natural way of building tolerance—by oral ingestion.
Research has shown that delivering food allergy treatment through the gut/gastrointestinal tract enables people to build up a level of tolerance against potential reactions due to accidental exposures.
Building on a century of OIT research, we’re applying Aimmune’s investigational Characterized Oral Desensitization Immunotherapy (CODIT™) platform as a standardized approach to treat food allergies. CODIT™ is based on 3 key elements:
  • A standardized OIT protocol with precise oral dosing
  • Pharmaceutical grade products
  • Training and education
Our unique platform involves a patient ingesting controlled, increasing amounts of pharmaceutical grade allergen protein. Over time, the patient’s immune system begins to tolerate larger amounts of the allergen. Those levels are then maintained with a consistent therapeutic dose.
A Standardized Protocol With Precise Dosing
With our investigational CODIT™ platform, initial administration of a particular dose of food allergen is done in an allergist’s office, and subsequent administrations are done at home until the next up-dosing in the allergist’s office. After completing the dose-escalation period, patients take a daily therapeutic dose to maintain desensitization while continuing to avoid exposure to their food allergens and carrying epinephrine auto-injectors, which may reduce the fear and anxiety of accidental exposure.

Food Allergy Treatments in Development

Our portfolio of development programs targets the most prevalent food allergies—starting with peanut—using our investigational Characterized Oral Desensitization Immunotherapy (CODIT™) platform.

Program
  • PRE-IND
  • PHASE 1/2*
  • PHASE 3
  • APPROVED
phase
  • PRE-IND
  • PHASE 1/2*
  • PHASE 3
  • APPROVED
PH 1/2*

A second development program targeting egg allergy is underway.

  • PRE-IND
  • PHASE 1/2*
  • PHASE 3
  • APPROVED
PRE-IND

We are planning to initiate a third development program, targeting multi-tree nut allergy.

*Because our treatment product candidates are based on foods that have not shown toxicology issues except in their functions as allergens, we have not been required to and at this time do not anticipate conducting Phase 1 clinical trials.

Development Program

Looking beyond our current development portfolio, we are examining programs to treat additional common food allergies.
Nearly one-third of people with food allergies are allergic to more than 1 food. To help these people, we also are researching therapies that take a combination approach to desensitization


References:
1. National Institute of Allergy and Infectious Diseases, National Institutes of Health. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. 2011. https://www.niaid.nih.gov/sites/default/files/faguidelinespatient.pdf. Accessed July 18, 2019.
2. US Census Bureau. Quick facts. https://www.census.gov/quickfacts/fact/table/US/INC110217. Accessed July 18, 2019.
3. Gupta RS, Springston EE, Warrier MR, et al. The prevalence, severity, and distribution of childhood food allergy in the United States. Pediatrics. 2011;128(1):e9-e17.
4. European Academy of Allergy and Clinical Immunology (EAACI). Food allergy & anaphylaxis public declaration. http://www.eaaci.org/attachments/FoodAllergy&AnaphylaxisPublicDeclaration.pdf. Accessed July 1, 2019.
5. Clark S, Espinola J, Rudders SA, Banerji A, Camargo CA Jr. Frequency of US emergency department visits for food-related acute allergic reactions. J Allergy Clin Immunol. 2011;127(3):682-683.
6. Gupta R, Holdford D, Bilaver L, Dyer A, Holl JL, Meltzer D. The economic impact of childhood food allergy in the United States. JAMA Pediatr. 2013;167(11):1026-1031.
7. Food Allergy Research & Education (FARE). https://www.foodallergy.org/. Accessed September 25, 2019.
8. Cummings AJ, Knibb RC, King RM, Lucas JS. The psychosocial impact of food allergy and food hypersensitivity in children, adolescents and their families: a review. Allergy. 2010;65(8):933-945.
9. Flokstra-de Blok BM, Dubois AE, Vlieg-Boerstra BJ, et al. Health-related quality of life of food allergic patients: comparison with the general population and other diseases. Allergy. 2010;65(2):238-244.