by A monoclonal antibody treatment significantly increased the amounts of multiple common foods that food-allergic children and adolescents could consume without suffering an allergic reactionaccording to a planned interim analysis of an advanced clinical trial from the US National Institute of Allergy and Infectious Diseases.
The laboratory-made antibody, omalizumab, is approved by the American Medicines Agency (FDA) for three different indications of food allergy. The FDA is now reviewing a supplemental biologics license application for omalizumab for food allergy based on this interim analysis of the trial.
Additionally, the trial is supported by Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation. Both companies collaborate in the development and promotion of omalizumab, marketed as ‘Xolair’.
The first phase of the study was designed to evaluate the effectiveness of omalizumab in increasing the amount of food needed 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 team recruited children and adolescents from 1 to 17 years and three adults from 18 to 55 years old, all of them with confirmed allergy to peanuts and at least two other common foods.
In the planned interim analysis, the study’s independent Data and Safety Monitoring Board examined data from the first 165 children and adolescents who participated in the first phase of the trial. Using strict criteria, the Data and Safety Monitoring Board found that study participants who received omalizumab injections could consume higher doses of peanuts, eggs, milk and cashews without allergic reactions than participants who received placebo injections.
Based on these favorable results, the Data and Safety Monitoring Board recommended stopping enrollment in the first phase of the trial. The National Institute of Allergy and Infectious Diseases accepted the committee’s recommendation. In the future, more detailed information on the results will be available when they are published in a peer-reviewed journal.
