Intrommune Therapeutics, a biotech company dedicated to simplifying allergy immunotherapy, has announced the publication of its Phase 1 OMEGA (Oral Mucosal Escalation Goal Assessment) study, which evaluated the safety, tolerability, and adherence of a novel toothpaste-based treatment for peanut allergy in adults.
Intrommune’s proprietary Oral Mucosal Immunotherapy (OMIT) platform leverages INT301, a customized peanut protein, stabilized and embedded within a fully functional toothpaste. The principal mechanism involves administering OMIT with INT301 directly to the oral cavity using toothpaste as the delivery vehicle, facilitating consistent and targeted immune exposure to peanut allergen, a key requirement for effective desensitization.
The randomized, placebo-controlled trial, published in the journal Annals of Allergy, Asthma & Immunology, highlights the potential for OMIT to transform the landscape of peanut allergy treatment through the simple act of toothbrushing.
A total of 32 peanut-allergic adults were enrolled and assessed the safety and tolerability of increasing amounts of INT301 toothpaste. The findings demonstrated that OMIT with INT301 achieved an exceptional safety profile, with 100% of participants tolerating the highest dose they received. Encouragingly, there were no reports of anaphylaxis or severe systemic reactions in any of the treated participants and none of the study participants opted to withdraw from the study due to this novel treatment. Moreover, the non-systemic reactions that did occur were mostly mild, transient and localized to the mouth and lips. The robust safety profile coupled with an adherence rate of 97%, illustrates the patient-centric nature of this innovative approach.
Said Michael Nelson, CEO of Intrommune Therapeutics:
These findings represent a major step forward in our mission to develop patient-centered products for use in preventing and treating food allergies. The remarkable safety, tolerability, and adherence profile observed in the OMEGA trial elevates the potential of OMIT as a safe and convenient treatment option for individuals with peanut allergy.
Encouraged by these positive findings, Intrommune Therapeutics is committed to evaluating both the safety and efficacy of the OMIT platform in a larger trial of pediatric subjects with peanut and tree nut allergies.
- Intrommune Therapeutics Announces Publication of OMEGA Study in Peanut Allergic Adults in Annals of Allergy, Asthma & Immunology — Company Press Release
- Randomized, placebo-controlled, phase 1 safety study of oral mucosal immunotherapy in adults with peanut allergy — Annals of Allergy, Asthma & Immunology
