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Peanut Allergy Toothpaste Shown Safe in Trial

A woman brushing her teeth

(Martin Slavoljubovski, Pixabay.

10 Nov. 2023. Results of a clinical trial show a peanut allergy treatment formulated as a toothpaste can safely deliver immunotherapy to raise recipients’ peanut tolerance. A representative of Intrommune Therapeutics Inc. in New York, developer of the experimental peanut allergy therapy, is scheduled to present the findings tomorrow at a meeting of the American College of Allergy, Asthma and Immunology in Anaheim, California.

Peanut allergies are among the most common food allergies, where the immune system reacts to proteins in peanuts as a pathogen, with symptoms ranging from runny nose and skin irritation to life-threatening anaphylaxis. The prevalence of peanut allergy is increasing in Europe and North America, reaching 1.4 to 2.0 percent of the population. In Feb. 2020, as reported by Science & Enterprise, the Food and Drug Administration approved the first peanut allergy treatment for children that exposes recipients to increasing amounts of peanut allergens for six months to desensitize the immune system. Otherwise, people with peanut allergies need to take special care not to ingest food made with even a small amount of peanuts.

Intrommune Therapeutics takes a different approach to build peanut tolerance called oral mucosal immunotherapy or OMIT that the biotechnology company says uses mucous membranes in the oral cavity to desensitize the immune system. Intrommune’s lead product, code-named INT301, is formulated as a toothpaste to deliver peanut immunotherapy as part of a person’s daily tooth-brushing routine. INT301, says the company, is designed as a fully-functioning toothpaste with immunotherapy that transfers through the mouth lining to gradually increases users’ peanut allergen threshold, to where symptoms are no longer triggered by accidental exposure.

Ability to ingest peanut protein

The early-stage clinical trial enrolled 32 adults with peanut allergies at two sites in New Jersey. Participants were randomly assigned on a 3-to-1 basis to use INT301 in escalating doses or a placebo toothpaste over 48 weeks. The study team from Intrommune looked mainly for tolerance and adverse effects from using INT301 as well as adherence to the daily tooth-brushing regimen, finding the maximum tolerated dose and exploratory immunoglobulin biomarkers indicating an immune response. In a subset of participants, the team also tested the ability of participants to ingest 300 milligrams of peanut protein, equivalent to 1 to 1.5 peanuts, at the beginning and end of the 48-week test period.

The researchers report all participants were able to tolerate use of INT301 up to the highest dose of the treatment. Participants reported no more than mild temporary adverse reactions, mainly itching around the mouth. Nearly all (97%) adhered to the treatments, with no dropouts from the study. And the team says initial biomarker measures indicate an immune response among INT301 recipients. In addition, the company reports all of those in the small group using INT301 could ingest 300 milligrams of peanut protein at the end of the study, compared to half of those using the placebo.

William Berger, an allergist and consultant to Intrommune Therapeutics who led the study and is presenting the findings, says in a company statement, “OMIT appeared to be a safe and convenient option for adults with food allergies.” Michael Nelson, CEO of Intrommune adds that the company is designing a mid-stage clinical trial to test INT301 among children.

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