NIH Trial Shows Antibody Effectively Reducing Allergic Reactions to Multiple Foods

January 06, 2024

An ongoing advanced clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID) has shown promising results in the use of omalizumab, a monoclonal antibody, to expand the range of common foods tolerated by children and adolescents with food allergies. The trial, named Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH), is part of the NIAID-funded Consortium for Food Allergy Research (CoFAR) and is being conducted at 10 locations across the United States.

The interim analysis, conducted by the study's independent Data and Safety Monitoring Board (DSMB), focused on the first 165 children and adolescents aged 1 to 17 years who participated in the initial stage of the trial. Omalizumab, an FDA-approved antibody for indications other than food allergy, demonstrated its potential to increase the threshold for allergic reactions. Those who received omalizumab injections exhibited the ability to tolerate higher doses of peanut, egg, milk, and cashew without triggering allergic reactions compared to those who received placebo injections.

The FDA is currently reviewing a supplemental biologics license application for omalizumab for the treatment of food allergies, based on the promising outcomes observed in this interim analysis of the NIAID trial.