In a breakthrough study, researchers have found that a 16-week course of the monoclonal antibody omalizumab can protect children living with multiple food allergies in the case of accidental exposure.

According to the researchers, multi-food allergic children as young as one were able to consume an “increased amount” of peanut, tree nuts, egg, milk and wheat “without an allergic reaction” in a late stage clinical trial.

In the US alone, 5.8 million children live with food hypersensitivity, according to FoodAllergy.org. However, Johns Hopkins Medicine notes that nearly five percent of children under the age of five live with food allergies.

Leading the trial were Dr Robert Wood, M.D., Professor of Pediatric Allergy and Immunology at the Julie and Neil Reinhard and Director of the Pediatric Clinical Research Unit at the Johns Hopkins University School of Medicine as well as Dr Sharon Chinthrajah, M.D, Associate Professor of Medicine and of Pediatric Allergy and Clinical Immunology at Stanford University School of Medicine.

Looking at specific types of foods, eggs milk and peanuts were found to be the “most common causes of food allergies in children”, however wheat, soy and tree nuts were also included in this list. In addition, fish, shellfish, peanuts, and tree nuts were found to commonly cause “the most severe reactions”.

The trail however, published in The New England Journal of Medicine and presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting in Washington, D.C., found that participants that completed the antibody treatment were able to consumer a greater quantity of the foods tested without a moderate or severe allergic reaction compared to those that consumed a placebo.

In fact, nearly 67 percent of those involved in the study that completed the antibody treatment were able to consume a single dose of 600 milligrams or more of peanut protein (which is the equivalent to 2.5 peanuts) without experiencing a moderate or severe allergic reaction, in contrast with less than seven percent of participants who received placebo.

Similar outcomes were found when participants were tested for milk, egg, wheat, cashew, walnut and hazel however these foods were tested at a threshold dose of 1,000mg protein or more.

Published via the The National Institutes of Health website, the scientist said that they findings suggests the antibody therapy “has the potential to protect children and adolescents if they accidentally eat a food to which they are allergic despite efforts to avoid it”.

“People with food allergies and their caregivers need to maintain constant vigilance to avoid foods that could cause a potentially life-threatening allergic reaction. This is extremely stressful, especially for parents of young children,” said Jeanne Marrazzo, M.D., M.P.H., Director of the National Institute of Allergy and Infectious Diseases (NIAID).

“Although food avoidance remains critical, the findings reported today show that a medicine can help reduce the risk of allergic reactions to common foods and may provide protection from accidental exposure emergencies.”

NIAID and Genentech work in collaboration to develop omalizumab, which is marketed as Xolair. On 16 February 2024, the US Food and Drug Administration (FDA) approved omalizumab for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adults and children aged one year and older with food allergy.

FDA approval relied on the data obtained from a scheduled interim analysis of the Phase 3 NIAID trial. Despite using omalizumab, individuals were advised that they should continue to avoid foods they were allergic to. importantly, omalizumab has not been sanctioned for the emergency management of allergic reactions, including anaphylaxis.

Speaking to New Food about this updat from the FDA, and defining it as an “amazing allergy breakthrough”, Sterling Crew, President of the Institute of Food Science, said: “We now have another option for keeping our food hypersensitive consumers safe and minimising their allergic reactions to foods in accidental exposures.

“It is important to remember there is no cure for food hypersensitivity, Consumers must continue to avoid food that may cause an allergic reaction. The identification, control and communication of food allergens has always been a critical issue throughout the global food supply system,” continued Crew.

The first stage of the trial was designed by researchers to gauge whether taking omalizumab was able to increase the threshold for the amount of food that caused allergic reactions, and, in turn, reduce the likelihood of reactions to small amounts of food allergens during accidental exposure.

But how does it all work? The scientists have explained that omalizumab is able to bind the allergy-causing antibody called immunoglobulin E in the blood and preventing it from arming key immune cells responsible for allergic reactions, allowing the cells to become “much less sensitive to stimulation by any allergen”.

Extending its study, NIAID-funded Consortium for Food Allergy Research (CoFAR) will be conducting research across 10 locations in the US, involving 177 children and adolescents between the ages of one and 17 years. In addition, three adults will be tested beyween the ages of 18 and 55 who live with allergies to peanuts as well as at least two other common foods among milk, egg, cashew, wheat, hazelnut or walnut.

Commenting on the FDA’s approval of omalizumab for the reduction of allergic reactions and how food industry professions will need to continue to remain vigilant, Crew said: “Food Business Operators will have to continue to adopt best allergen management practices to protect their food hypersensitive customers from potentially deadly food allergies. At its most basic level, an allergen risk assessment within a Food Safety Management System involves examining any product or dish to understand its composition and production and thus the likelihood of allergen content.

“It is marvellous to see medical science providing solutions to help consumers who have food hypersensitivity. We now have another option for keeping affected consumer’s safe and minimising their allergic reactions to accidental exposure. An exposure which can cause life threatening reactions, as we have seen with a number of reported tragic deaths,” concluded Crew.

To read the full study, click this link.

Stay updated with New Food to read about any developments, as well as frequent allergy updates in the sector, including products being recalled due to incorrect allergen labelling.