Groundbreaking Study Demonstrates Safety and Tolerability of Oral Mucosal Immunotherapy (OMIT) for Peanut Allergy Using Toothpaste
NEW YORK, Feb. 19, 2025 (GLOBE NEWSWIRE) -- The global burden of food allergy has increased exponentially over the past few decades and represents a significant health concern. In the United States alone, an estimated 33 million individuals are affected by food allergies with peanut allergy being one of the most prevalent, persistent and severe food allergies. With only two FDA approved treatments, the cornerstone of management requires complete avoidance of the food allergen and the use of rescue medication. This presents significant challenges for food allergic individuals due to the ongoing risk of accidental exposure, underscoring a critical unmet need for effective and convenient treatments.
Today, Intrommune Therapeutics, Inc. is excited to announce the publication of a its Phase 1 OMEGA (Oral Mucosal Escalation Goal Assessment) study evaluating the safety, tolerability, and adherence of a novel toothpaste-based treatment for peanut allergy in adults. Intrommune’s proprietary Oral Mucosal Immunotherapy (OMIT) platform using 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 which facilitates consistent and targeted immune exposure to peanut allergen, a key requirement for effective desensitization.
The randomized, placebo-controlled trial, published in the prestigious Annals of Allergy, Asthma & Immunology, marks a significant advancement in food allergy immunotherapy and highlights the potential for OMIT to transform the landscape of peanut allergy treatment through the simple act of toothbrushing. The study, titled a “Randomized, Placebo-Controlled, Phase 1 Safety Study of Oral Mucosal Immunotherapy in Peanut Allergic Adults,” enrolled 32 peanut-allergic adults 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.
“These findings represent a major step forward in our mission to develop patient-centered products for use in preventing and treating food allergies,” stated Michael Nelson, CEO at Intrommune Therapeutics. “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.
Read a ‘Randomized, Placebo-Controlled Phase 1 Safety Study of Oral Mucosal Immunotherapy in Peanut Allergic Adults’ here: https://www.annallergy.org/article/S1081-1206(25)00040-7/fulltext
About Intrommune Therapeutics: Intrommune Therapeutics is dedicated to developing innovative and patient-friendly products for use in preventing and treating food allergies. The company’s proprietary Oral Mucosal Immunotherapy (OMIT) platform aims to revolutionize food allergy treatment by delivering allergenic proteins through a convenient toothpaste, targeting the oral mucosa for desensitization. Intrommune is committed to improving the lives of millions affected by food allergies worldwide.
Contact:
Nicole Faris
Intrommune Therapeutics
nfaris@intrommune.com
+1-206-499-3779
Cautionary Statement Regarding Forward Looking Statements
This release may contain “forward-looking statements.” Forward-looking statements are identified by certain words or phrases such as “may,” “will,” “aim,” “will likely result,” “believe,” “expect,” “will continue,” “anticipate,” “estimate,” “intend,” “plan,” “contemplate,” “seek to,” “future,” “objective,” “goal,” “project,” “should,” “will pursue” and similar expressions or variations of such expressions. These forward-looking statements reflect the company’s current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the company. The company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.
This release does not contain or constitute an offer to sell or a solicitation of any offer to buy securities in the United States or in any other jurisdiction.
