In a study involving patients who experienced food allergies, oral mucosal immunotherapy (OMIT) stood out as a secure and convenient alternative. OMIT employs a uniquely formulated toothpaste to target immunologically active areas in the oral cavity, maximizing the potential for food allergy desensitization. Hence, this randomized phase 1 OMEGA trial was executed to evaluate the safety of OMIT in adults afflicted with peanut allergies.

In this investigation, 32 adults, aged 18-55, with peanut allergies were included, with a ratio of 3:1 for receiving either an escalating dose of INT301 or a placebo. Inclusion criteria consisted of a positive skin prick test having a wheal diameter at least 3 mm greater when compared to the control and/or psIgE ≥ 0.35 kU/L. Furthermore, participants were mandated to be unsuccessful in an oral food challenge involving ≤ 100 mg of peanut protein. Throughout the 48-week trial, the safety profile was under constant observation during both the up-dosing and maintenance phases, with an assessment of exploratory biomarkers.

All active subjects demonstrated a consistent tolerance of the highest dose specified in the protocol, with no occurrence of moderate or severe systemic reactions among them. Local and mild adverse reactions, primarily manifesting as oral itching, constituted the majority of non-systemic events and were of a transient nature. Notably, 97% adhered to treatment, and no participants dropped out due to medication-related issues. The exploratory biomarkers within a designated subset of subjects remained consistent with an immunologic response to the treatment.

The trial demonstrated that INT301 fulfilled both primary and secondary endpoints, achieving a favorable adherence and safety profile. This indicates that OMIT provides a safe and convenient choice for food allergy management. The observed immunologic response to the treatment indicates the need for additional evaluation. These findings endorse the ongoing development of INT301 in the pediatric population.