Randomized, placebo-controlled, phase 1 safety study of oral mucosal immunotherapy in adults with peanut allergy.

Abstract

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

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

Methods: The Oral Mucosal Escalation Goal Assessment study enrolled 32 adults, aged 18 to 55 years, with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or a placebo. Entry criteria included a positive skin prick test result with a wheal diameter greater than or equal to 3 mm than control and/or peanut-specific IgE level greater than or equal to 0.35 kU/L. Subjects were required to fail an oral food challenge less than or equal to 100 mg dose of peanut protein. Safety and tolerability were monitored in the 48-week trial period.

Results: All active subjects (100%) tolerated the prespecified protocol at the highest dose. No moderate or severe systemic reactions were observed in the active participants. Nonsystemic adverse reactions were mostly local (oral and nasal cavities), mild and transient. Active subjects adhered to the treatment for 97% of the days in the study, with no withdrawals due to study medication.

Conclusion: In the Oral Mucosal Escalation Goal Assessment trial, INT301 met all primary and secondary end points of safety, tolerability, and adherence. Thus, OMIT seems to be a safe and convenient option for individuals with food allergies. These results support the need for further evaluation in the pediatric population.

Trial registration: ClinicalTrials.gov Identifier: NCT04603300.