In a promising development, a monoclonal antibody treatment has demonstrated a significant increase in the amount of various common foods that children and adolescents with food allergies could consume without experiencing an allergic reaction. The findings are based on a planned interim analysis of an advanced clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH).
The laboratory-made antibody, known as omalizumab, has already received approval from the Food and Drug Administration (FDA) for three indications unrelated to food allergies. A supplemental biologics license application for omalizumab for food allergy is currently under FDA review, with the decision informed by the interim analysis of the NIAID trial.
Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation are providing support for the trial and collaborating on the development and promotion of omalizumab, marketed as Xolair.
The multi-stage trial, named Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH), is conducted by the NIAID-funded Consortium for Food Allergy Research (CoFAR) at ten locations across the United States.
In the first stage of the study, researchers aimed to evaluate the efficacy of omalizumab in increasing the threshold for allergic reactions to food, thereby reducing the likelihood of reactions to small amounts of food allergens in accidental exposures. The trial enrolled children and adolescents aged 1 to 17 years and three adults aged 18 to 55 years, all confirmed to have allergies to peanuts and at least two other common foods.
In the planned interim analysis, the independent Data and Safety Monitoring Board (DSMB) examined data from the first 165 children and adolescents participating in the trial’s initial stage. The DSMB, using stringent criteria, observed that participants receiving omalizumab injections could tolerate higher doses of peanut, egg, milk, and cashew without allergic reactions compared to those receiving placebo injections.
Encouraged by these positive results, the DSMB recommended halting enrollment in the first stage of the trial, a recommendation accepted by NIAID. Detailed findings will be available upon publication in a peer-reviewed journal.
NIAID, operating under the NIH, conducts and supports research on infectious and immune-mediated diseases, striving to develop improved methods of prevention, diagnosis, and treatment.
About the National Institutes of Health (NIH): NIH, the leading medical research agency in the United States, comprises 27 Institutes and Centers and operates within the U.S. Department of Health and Human Services. It conducts and supports various medical research endeavors, exploring causes, treatments, and cures for common and rare diseases.
