Randomized, Placebo-Controlled, Phase 1 Safety Study of Oral Mucosal Immunotherapy in Peanut Allergic Adults.

Background: Oral Mucosal Immunotherapy (OMIT) uses a specifically formulated toothpaste to deliver allergenic proteins to immunologically active areas of the oral cavity. This represents a new delivery mechanism with several features designed to improve food allergy desensitization. OMIT presents advantages over other approaches to allergy immunotherapy due to its targeted delivery and simplified administration.

Objective: To determine the safety, tolerability, and adherence of OMIT with INT301 in peanut allergic adults.

Methods: This Oral Mucosal Escalation Goal Assessment (OMEGA) 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. Entry criteria included a positive SPT with a wheal diameter ≥ 3mm greater than control and/or psIgE ≥ 0.35 kU/L. Subjects were required to fail an oral food challenge ≤ 100 mg dose of peanut protein. Safety and tolerability were monitored during this 48-week trial.

Results: 100% of active subjects tolerated the pre-specified protocol highest dose. No moderate nor severe systemic reactions occurred in active participants. Non-systemic adverse reactions were mostly local (oral and nasal cavity), mild and transient. Active subjects adhered to treatment 97% of days on study, with no withdrawals due to study medication.

Conclusion: In the OMEGA trial, INT301 met all primary and secondary endpoints of safety, tolerability, and adherence. OMIT appears to be a safe and convenient option for individuals with food allergies. These results support its further evaluation in the pediatric population.