Scientific Study

Introduction: Oral Mucosal Immunotherapy (OMIT) uses a specially formulated toothpaste to deliver allergenic proteins to immunologically active areas of the oral cavity, a delivery mechanism which has the greatest potential for food allergy desensitization. OMIT presents advantages over other approaches to allergy immunotherapy due to its targeted delivery and simplified administration, supporting the goal of improved adherence. Methods: This study enrolled 32 adults, age 18-55, with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. Inclusion criteria included a positive SPT with a wheal diameter at least 3mm greater than control and/or psIgE ≥ 0.35 kU/L. Additionally, subjects were required to fail an oral food challenge ≤ 100 mg of peanut protein. During this 48-week trial, safety profile was monitored during the up-dosing and maintenance phases. Exploratory biomarkers were evaluated. Results: 100% of active subjects consistently tolerated the pre-specified protocol highest dose. No moderate nor severe systemic reactions in active participants. Non-systemic adverse reactions were mostly local (oral itching), mild and transient. 97% adherence to treatment with no dropouts due to study medication. Exploratory biomarkers were consistent with an immunologic response to treatment in a designated subset of subjects. Conclusion: In this phase 1 OMEGA trial, adherence and safety profile of INT301 successfully achieved the primary and secondary endpoints. OMIT appears to be a safe and convenient option for individuals with food allergies. Immunologic response to treatment suggests further evaluation. These results support continued development of INT301 in the pediatric population. https://doi.org/10.1016/j.anai.2023.10.023