Drug in OUtMATCH clinical trial FDA-approved for the reduction of allergic reactions from accidental food exposures

CHAPEL HILL, N.C. – Millions of Americans have food allergies, and about 40% of children with food allergies are allergic to more than one food, according to Food Allergy Research & Education (FARE). However, new research from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, suggests an FDA-approved antibody therapy has the potential to reduce allergic reactions in children and adults if they accidentally eat a food to which they are allergic despite efforts to avoid it.

On February 16, 2024, the Food and Drug Administration 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 1 year and older with food allergy. The FDA approval was based on data from a planned interim analysis of the Phase 3 NIAID trial. People taking omalizumab still need to avoid foods they are allergic to. Omalizumab is not approved for the emergency treatment of allergic reactions, including anaphylaxis.

Published in the New England Journal of Medicine, results from the OUtMATCH clinical trial, showed how a 16-to-20-week course of the monoclonal antibody omalizumab increased the amount of peanut, tree nuts (cashew, hazelnut and walnut), egg, milk and wheat that multi-food allergic children as young as one-year could consume without a moderate or severe allergic reaction. Nearly 67% of participants who completed the treatment could consume a single dose of 600 milligrams (mg) or more of peanut protein, compared to less than 7% of participants who received placebo with 600 mg representing approximately 2.5 peanuts. This was at least 6 times the amount of peanut protein that participants could tolerate at the start of the trial. Treatment with omalizumab also yielded similar outcomes for egg, milk, wheat, cashew, walnut and hazelnut at a threshold dose of 1,000 mg protein or more.

Robert Wood, MD, corresponding author, Julie and Neil Reinhard Professor of Pediatric Allergy and Immunology and director of the Pediatric Clinical Research Unit at the Johns Hopkins University School of Medicine and Sharon Chinthrajah, MD, associate professor of medicine and of pediatric allergy and clinical immunology at Stanford University School of Medicine, led the trial. Contributing authors from the UNC School of Medicine include: Corinne Keet, MD, PhD, professor of pediatrics and associate director of UNC Children’s Research Institute; Mike Kulis, PhD, pediatric allergy and immunology associate professor and member of UNC Children’s Research Institute; and Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the UNC Food Allergy Initiative at the UNC School of Medicine.

“Current food allergy treatments, such as oral immunotherapy (OIT) or sublingual immunotherapy (SLIT), must be tailored for patients allergic to individual foods, such as peanuts,” said Dr. Kim. Based on the OUtMATCH results, patients could be allergic to one food or all of the included foods and experience reduced allergic reactions from a single treatment with omalizumab, which could change the way allergists treat food allergy in clinical practice, according to Dr. Kim.

Living with food allergy requires constant vigilance. It’s a condition that causes detrimental effects on nutrition in-take and quality of life, including social and emotional challenges faced by individuals and their families. Successfully avoiding specific foods can be difficult, particularly for patients with allergy to multiple foods. Not only that, but individuals face the risk of severe to life-threatening reactions such as, hives, swelling, and anaphylaxis.

The first stage of the phase 3 OUtMATCH trial was designed to see if taking omalizumab increased the threshold for the amount of food that caused allergic reactions, thereby reducing the likelihood of reactions that might occur as a result of accidental exposures. The study team enrolled 177 children and adolescents ages 1 to 17 years and three adults ages 18 to 55 years, all with confirmed allergy to peanut and at least two other common foods among milk, egg, cashew, wheat, hazelnut or walnut. Volunteers who reacted to small amounts of these food allergens during oral food challenges were assigned at random to receive injections of either omalizumab or placebo. After 16 to 20 weeks of treatment, the participants were challenged again in a carefully controlled setting to see if they could tolerate a greater amount of food than they did at the outset.

Investigators examined whether omalizumab injections led to a statistically significant increase in the proportion of participants who could consume roughly the equivalent of 2.5 peanuts without a moderate or severe allergic reaction, up from less than half a peanut at the outset, and similarly greater quantities of milk, egg or cashew among people allergic to those foods. The first 60 participants who completed stage one entered a 24-week open-label extension of omalizumab injections followed by additional oral food challenges. Most participants who had received omalizumab during the first stage of the trial maintained or increased the amount of food protein they could consume without an allergic reaction during the extension.

Omalizumab – developed by Genentech and Novartis Pharmaceuticals Corporation and marketed as Xolair – works by targeting and blocking the allergic antibody IgE. The treatment received initial FDA approval in 2003 for moderate-to-severe persistent allergic asthma and received subsequent indications for chronic urticaria in 2014 and chronic rhinosinusitis with nasal polyps in 2020.

People who receive omalizumab would need to continue avoiding foods to which they are allergic and ongoing dosing will be required. Omalizumab should not be used for the emergency treatment of any allergic reactions, including anaphylaxis.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is the regulatory sponsor of the OUtMATCH trial. The NIAID-funded Consortium for Food Allergy Research (CoFAR) is conducting OUtMATCH at 10 locations across the United States. NIAID funds the ongoing trial with additional support from and collaboration with Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation. The National Center for Advancing Translational Sciences (NCATS), also part of NIH, supports some of the staff, space and services used to conduct the trial.

NIAID and NCATS fund OUtMATCH through grant award numbers UM2AI130836, UM1AI130838, UL1TR003098, UM1TR004406, UM1TR004408, UM1AI130570, UM1AI130839, UM1AI130936, UL1TR002535, UM1TR004399, UL1TR001878, UM1AI130781, and UL1TR002378. The content of this press release is soley the responsibility of the University of North Carolina and does not represent the official views of the National Institutes of Health.

Media contact: Brittany Phillips, Communications Specialist, UNC Health | UNC School of Medicine