Nov. 16, 2023 – A new toothpaste is showing promise as a treatment to help adults who are allergic to peanuts tolerate increasing amounts of peanut protein.
The investigational toothpaste is labeled INT301 and it met its safety goals in an early randomized, placebo-controlled trial.
Thirty-two adults, ages 18-55, who were allergic to peanuts, were enrolled in the 4-month trial. The participants were randomly placed into groups that received either increasing amounts of the peanut protein in the toothpaste to test how much they could tolerate safely or a placebo toothpaste that had no peanut proteins. The toothpaste was squeezed from a metered dispenser to control the amount.
Neither the person giving the participants the toothpaste, nor the patient knew which kind of toothpaste they got, to help eliminate potential bias.
“INT301 demonstrated safety across all treatment groups,” said the study’s lead author, William Berger, MD, an allergist and consultant for Intrommune, a biotechnology company based in New York City, which developed the toothpaste.
The toothpaste is a form of oral immunotherapy and it exposes the body to an allergen in tiny but increasing amounts over time to build tolerance in case a person is accidentally exposed to peanuts. Unlike some other oral immunotherapies, this one targets cells not just under the tongue, but in many parts of the mouth with the greatest potential for allergy desensitization, Berger said.
Berger presented the findings of the OMEGA (Oral Mucosal Escalation Goal Assessment) trial Nov. 11 at the American College of Allergy, Asthma and Immunology Annual Meeting in Anaheim, CA.
All Tolerated the Highest Dose
All participants in the treatment arm consistently tolerated the highest dose. In addition, there were no moderate or severe side effects, Berger said.
The main reaction for those who got the treatment toothpaste was mild itching inside the mouth that could be eliminated with antihistamines.
Trial regulators had asked the investigators to watch for any dental side effects and Berger said the toothpaste did not cause health in the teeth or mouth.
Early Signs it is Effective
This early study was primarily a safety trial, but the investigators also found signs with blood tests that the toothpaste works to help desensitize adults to peanut protein. Effectiveness will be explored further in a future trial.
Kristin Sokol, MD, MPH, an allergist/immunologist with Schreiber Allergy in Rockville, MD, said, “As of now, the only options we have for food allergy treatment and management are to tell our patients to completely avoid a food and carry epinephrine for their entire lives,” another oral immunotherapy.
Oral immunotherapy is time consuming, and there are substantial logistic considerations. This toothpaste offers an easier option that families can fit into their daily schedules, she said.
“I’m always looking for options like that,” Sokol said. “Obviously there are more studies that need to be done. I really like the safety data on this. The zero incidence of anaphylaxis is really important.”