Genentech announced key findings from Stage 1 of the NIH-sponsored Phase III OUtMATCH study, published in the New England Journal of Medicine (NEJM) and presented at the 2024 AAAAI Annual Meeting. The study demonstrated that treatment with Xolair® (omalizumab) raised the threshold amount of allergens such as peanuts, milk, egg, wheat, and tree nuts (cashew, hazelnut, and walnut) needed to cause moderate to severe allergic reactions in individuals with multiple food allergies, as young as 1 year old. These safety findings align with Xolair’s established safety profile across approved indications and prior clinical trials.
The U.S. FDA has recently approved Xolair for expanded use in children and adults with IgE-mediated food allergies, based on data from this OUtMATCH study.
Dr. Robert Wood, principal investigator of the OUtMATCH study, highlighted the debilitating nature of food allergies and the limited treatment advancements. The study results indicate that anti-IgE therapy, such as Xolair, could substantially reduce allergic reactions from accidental exposures across multiple foods.
Dr. R. Sharon Chinthrajah, co-lead study investigator, also emphasized the significant impact food allergies have on patients and their families. The OUtMATCH study findings suggest that Xolair treatment can increase most patients’ thresholds for allergic reactions, potentially mitigating the risks associated with accidental exposures.
In total, 180 patients aged from 1 to 55 years entered Stage 1 of the study with intolerance to specific quantities of allergens. Following treatment, patients could tolerate higher amounts of these allergens without severe reactions. This points to Xolair as an important new treatment option that could reduce the risk of severe allergic responses to food for individuals with multiple allergies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.