November 8, 2023
New study shows specially formulated toothpaste successful in peanut immunotherapy for adults
ANAHEIM, Calif. (Nov. 9, 2023) – Oral immunotherapy for peanut allergy – introducing small amounts of peanut over a period of time to cause less of a reaction if the person eats something with peanut – has been used by allergists for years to help desensitize those with peanut allergy. A new late breaking abstract being presented at this year’s American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting in Anaheim, Calif. demonstrates that a specially formulated toothpaste can be successfully used for Oral Mucosal Immunotherapy (OMIT).
“OMIT uses a specially formulated toothpaste to deliver allergenic peanut proteins to areas of the oral cavity,” says allergist William Berger, MD, ACAAI member and author of the study. “OMIT as a delivery mechanism for peanut protein has great potential for food allergy desensitization. Due to its targeted delivery and simple administration, it supports the goal of improved adherence.”
This study enrolled 32 adults, age 18-55, with peanut allergy in a 3:1 ratio of active treatment to placebo control. Participants received either an escalating dose of peanut toothpaste or placebo. During this 48-week trial, safety was monitored during the up-dosing and maintenance phases. Exploratory biomarkers were also evaluated, and oral food challenges were conducted. (Exploratory biomarkers are blood tests used to show if a person’s immune system is responding to treatment with an allergen such as peanut.)
“We noted that 100% of those being treated with the toothpaste consistently tolerated the pre-specified protocol highest dose,” says Dr. Berger. “No moderate nor severe systemic reactions occurred in active participants. Non-systemic adverse reactions were mostly local (oral itching), mild, and transient. There was 97% adherence to treatment with no dropouts due to study medication. OMIT appears to be a safe and convenient option for adults with food allergies. The results support continued development of this toothpaste in the pediatric population.”
Additional long-term studies are planned to further evaluate the ongoing use of the toothpaste therapy to provide long-term protection against accidental ingestion of peanut.
Late Breaking Abstract
Title: A Randomized, Placebo-Controlled Phase 1 Safety Study of OMIT in Adults with Peanut Allergy
Presenter: William Berger, MD
For more information about food allergies and anaphylaxis, or to find an allergist in your area, visit AllergyandAsthmaRelief.org. The ACAAI Annual Scientific Meeting is Nov. 9-13. For more news and research from the ACAAI Scientific Meeting, go to our newsroom and follow the conversation on X/Twitter #ACAAI23.
About ACAAI
The American College of Allergy, Asthma & Immunology (ACAAI) is a professional medical organization of more than 6,000 allergists-immunologists and allied health professionals, headquartered in Arlington Heights, Ill. Founded in 1942, the College fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy, and research. ACAAI allergists are board-certified physicians trained to diagnose allergies and asthma, administer immunotherapy, and provide patients with the best treatment outcomes. For more information and to find relief, visit AllergyandAsthmaRelief.org. Join us on Facebook, Pinterest, Instagram and Twitter/X.
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A RANDOMIZED, PLACEBO-CONTROLLED PHASE 1 SAFETY STUDY OF OMIT IN ADULTS WITH PEANUT ALLERGY.
W. Berger*, New York, NY.
Introduction: Oral Mucosal Immunotherapy (OMIT) uses a specially formulated toothpaste to deliver allergenic proteins to immunologically active areas of the oral cavity, a delivery mechanism which has the greatest potential for food allergy desensitization. OMIT presents advantages over other approaches to allergy immunotherapy due to its targeted delivery and simplified administration, supporting the goal of improved adherence.
Methods: This study enrolled 32 adults, age 18-55, with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. Inclusion criteria included a positive SPT with a wheal diameter at least 3mm greater than control and/or psIgE ≥ 0.35 kU/L. Additionally, subjects were required to fail an oral food challenge ≤ 100 mg of peanut protein. During this 48-week trial, safety profile was monitored during the up-dosing and maintenance phases. Exploratory biomarkers were evaluated.
Results: 100% of active subjects consistently tolerated the pre-specified protocol highest dose. No moderate nor severe systemic reactions in active participants. Non-systemic adverse reactions were mostly local (oral itching), mild and transient. 97% adherence to treatment with no dropouts due to study medication. Exploratory biomarkers were consistent with an immunologic response to treatment in a designated subset of subjects.
Conclusion: In this phase 1 OMEGA trial, adherence and safety profile of INT301 successfully achieved the primary and secondary endpoints. OMIT appears to be a safe and convenient option for individuals with food allergies. Immunologic response to treatment suggests further evaluation. These results support continued development of INT301 in the pediatric population.
