A novel toothpaste, named INT301, is demonstrating potential as a breakthrough treatment aiding adults afflicted with peanut allergies in tolerating increasing amounts of peanut protein.
In an initial randomized trial focusing on safety, the investigational toothpaste met its safety benchmarks. Thirty-two adults, aged 18-55 and allergic to peanuts, were enrolled in this 4-month trial. Participants were divided randomly into groups receiving either escalating doses of peanut protein-infused toothpaste to assess their tolerance levels or a placebo toothpaste lacking peanut proteins. The toothpaste was dispensed via a metered dispenser to regulate the dosage. To minimize bias, neither the administrators nor the patients were aware of the type of toothpaste they received.
Dr. William Berger, an allergist and consultant for Intrommune, the New York-based biotechnology company behind the toothpaste, reported, “INT301 demonstrated safety across all treatment groups.”
This toothpaste operates as a form of oral immunotherapy, gradually exposing the body to minute yet increasing amounts of the allergen over time to develop tolerance in case of accidental peanut exposure. Distinguishing itself from other oral immunotherapies, this toothpaste targets cells not just beneath the tongue but in various oral regions with high potential for desensitization to allergies, explained Berger.
Presented at the American College of Allergy, Asthma and Immunology Annual Meeting, the OMEGA trial showcased that all individuals in the treatment group consistently tolerated the highest dosage with no moderate or severe side effects. Minor mouth itching, manageable with antihistamines, was the primary reaction among those using the treatment toothpaste.
Notably, the toothpaste did not induce any adverse dental effects, as confirmed by Berger, satisfying the trial regulators’ concerns.
While primarily a safety trial, the study also exhibited promising signs through blood tests, suggesting the toothpaste’s efficacy in desensitizing adults to peanut protein. The extent of its effectiveness will be explored further in subsequent trials.
Dr. Kristin Sokol, an allergist/immunologist at Schreiber Allergy in Rockville, MD, expressed enthusiasm for such alternatives in food allergy treatment. Sokol highlighted the current reliance on instructing patients to entirely avoid certain foods and carry epinephrine indefinitely—an oral immunotherapy which demands substantial time and logistics. This toothpaste, Sokol emphasized, presents a more manageable option for families to incorporate into their daily routines. She emphasized the significance of the safety data, particularly the absence of anaphylaxis incidents. However, Sokol stressed the necessity for further studies to solidify these findings.