Latest news with #IntrommuneTherapeutics
Associated Press
28-05-2025
- Business
- Associated Press
Intrommune Therapeutics Announces Independent Editorial Highlighting Breakthrough Safety Data for Novel Toothpaste Peanut Allergy Treatment
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 [email protected] (555) 123-4567 Cautionary Statement Regarding Forward-Looking Statements
Yahoo
24-02-2025
- Health
- Yahoo
Intrommune Therapeutics Announces Publication of OMEGA Study in Peanut Allergic Adults in Annals of Allergy, Asthma & Immunology
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 ' here: 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 FarisIntrommune Therapeuticsnfaris@ +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 in to access your portfolio
