Intrommune Therapeutics Announces Independent Editorial Highlighting Breakthrough Safety Data for Novel Toothpaste Peanut Allergy Treatment

/EIN News/ -- NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) -- As the burden of food allergies continues to increase each year, the need for safe, effective, and convenient treatments has never been greater. Over 33 million Americans suffer from food allergies, including nearly 6 million children. Approximately 2% of the population suffers from peanut allergy, which is known to be one of the most prevalent, persistent and severe food allergies. With its poor spontaneous resolution, peanut allergy persists in up to 80% of cases and significantly impacts the quality of life of sufferers and their families. With no known cure, the cornerstone of management relies on strict avoidance and rescue medications, often leaving patients and their families in near constant fear of accidental exposures and severe reactions.

Intrommune Therapeutics welcomes an independent editorial that was recently published in Annals of Allergy, Asthma & Immunology which underscores the potential of its innovative Oral Mucosal Immunotherapy (OMIT) platform to transform peanut allergy treatment. The editorial, entitled “Can daily teeth brushing help treat your peanut allergy,” authored by leading allergists, Dr. Aikaterini Anagnostou and Dr. David Stukus, discusses the key findings of the OMEGA (Oral Mucosal Escalation Goal Assessment) trial, a randomized, double blind placebo-controlled Phase 1 study, evaluating the safety of its investigational treatment, OMIT with INT301 (peanut protein) in peanut allergic adults. The authors acknowledge that the candidate therapy met all its primary and secondary endpoints, achieving exceptional safety and tolerability, with no moderate or severe systemic reactions or anaphylaxis reported in treated participants. Mild systemic reactions that did occur were reported less frequently in treated (4.2%) compared to control (25%) participants. Additionally, treated participants demonstrated robust adherence to the investigational treatment protocol, adhering to OMIT with INT301 97% of study days.

The authors also alluded to an interesting finding on the potential immunomodulatory effects of OMIT with INT301, specifically, the statistically significant increase in peanut-specific IgG4 levels, which they referenced as providing preliminary evidence of its “desensitization effects” in treated participants. Stukus and Anagnostou went on to address the potential benefits of OMIT with INT301 over existing immunotherapies, oral immunotherapy (OIT) and epicutaneous immunotherapy (EPIT), including “lower risk of anaphylaxis and fewer limitations in daily life in terms of activity restrictions,” and remarked that “OMIT represents an exciting future option.’’

Recognizing the potential of OMIT with INT301, the authors stress that expanded studies in pediatric populations and longer-term efficacy evaluation data are highly warranted. This aligns with the company’s intent to advance to a Phase 2/3 trial in pediatric patients to evaluate both the safety and efficacy of OMIT with INT301. According to Berger et al., in the April 2025 edition of the Annal of Allergy Asthma and Immunology, “evaluating OMIT in children is critically important, given that childhood may represent the most opportune time to induce a durable immunologic response and, potentially, clinical remission of peanut allergy.” In their concluding commentary, Drs. Anagnostou and Stukus stress the need for personalized, patient-centered care, including diverse options in food allergy management, for which OMIT may provide a unique alternative.

In response to the editorial, Michael Nelson, Chief Executive Officer of Intrommune commented, "We are encouraged by the interest in our innovative oral mucosal immunotherapy platform and this independent review underscores the scientific validity of the OMEGA results. If proven efficacious, OMIT’s safety and simplicity could revolutionize how families manage food allergies."

About Intrommune Therapeutics
Intrommune Therapeutics is a clinical-stage biotechnology company dedicated to developing safe, effective and easy-to-use food exposure products for the prevention and treatment of food allergies. Its OMIT platform leverages the oral mucosa’s immunologic properties to deliver targeted immunomodulation via a fully-functional toothpaste.

Intrommune Contact:
Nicole Faris (MSc.)
Strategic Director, Medical Affairs & Clinical Development
Intrommune Therapeutics
nfaris@intrommune.com
(555) 123-4567

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