Antibody reduces allergic reactions to different foods in NIH Trial

In a recent advanced clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), researchers found that a monoclonal antibody treatment called omalizumab increased the amount of multiple common foods that food-allergic children and adolescents could consume without an allergic reaction.

This treatment is a lab-made antibody that is already FDA-approved for three indications other than food allergy. The FDA is currently reviewing a supplemental biologics license application for omalizumab for food allergy based on this interim analysis of the NIAID trial. The study, called Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH), is being conducted by the NIAID-funded Consortium for Food Allergy Research (CoFAR) at 10 locations across the United States.

The first stage of the study aims to evaluate the effectiveness of omalizumab in increasing the amount of food that it takes to cause an allergic reaction, thereby reducing the likelihood of reactions to small amounts of food allergens in the event of accidental exposure. The study enrolled 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.

In the planned interim analysis, the study’s independent Data and Safety Monitoring Board (DSMB) examined data on the first 165 children and adolescents who participated in the first stage of the trial. The DSMB found that study participants who received omalizumab injections could consume higher doses of peanut, egg, milk, and cashew without allergic reactions than participants who received placebo injections.

Based on these favorable results, the DSMB recommended halting enrollment into the first stage of the trial, and NIAID accepted the board’s recommendation. More detailed information about the findings will become available when they are published in a peer-reviewed journal. The trial has support from Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation, the two companies collaborating to develop and promote omalizumab, marketed as Xolair, and are supplying it for the trial.

You can find additional information about the ongoing OUtMATCH trial at ClinicalTrials.gov under study identifier NCT03881696.