November 16, 2023 – A brand new toothpaste shows promising leads to the treatment of adults with peanut allergy, designed to enhance the tolerance of accelerating amounts of peanut protein.
The investigational toothpaste known as INT301 and met its safety objectives in an early randomized, placebo-controlled study.
The four-month study involved 32 adults aged 18 to 55 who were allergic to peanuts. Participants were randomly assigned to receive either increasing amounts of the peanut protein within the toothpaste to check how much they may safely tolerate, or a placebo toothpaste without peanut proteins. The toothpaste was squeezed out of a dispenser to manage the quantity.
To eliminate possible bias, neither the one who gave the participants the toothpaste nor the patient themselves knew what style of toothpaste they were receiving.
“INT301 was found to be safe in all treatment groups,” said the study's lead writer, Dr. William Berger, an allergist and consultant to Intrommune, a New York City-based biotechnology company that developed the toothpaste.
The toothpaste is a type of oral immunotherapy and exposes the body to an allergen in tiny but increasing amounts over time to accumulate a tolerance in case an individual is unintentionally exposed to peanuts. Unlike another oral immunotherapies, this one targets not only cells under the tongue but many other parts of the mouth which have the best potential for allergy desensitization, Berger said.
Berger presented the outcomes of the OMEGA (Oral Mucosal Escalation Goal Assessment) study on November 11 on the annual meeting of the American College of Allergy, Asthma and Immunology in Anaheim, California.
All tolerated the best dose
All participants within the treatment arm tolerated the best dose well. In addition, no moderate or severe uncomfortable side effects occurred, Berger said.
The important response in those that received the treatment toothpaste was mild itching within the mouth, which may very well be relieved with antihistamines.
The study's regulator had asked researchers to observe for any uncomfortable side effects on teeth, and Berger said the toothpaste had no health effects on teeth or mouth.
Early signs of effectiveness
This early study was primarily a security test, but researchers also found evidence in blood tests that the toothpaste helps desensitize adults to peanut protein. Its effectiveness shall be further studied in a future test.
Kristin Sokol, MD, MPH, allergist/immunologist at Schreiber Allergy in Rockville, MD, said, “The only options we currently have for treating and managing food allergies are to tell our patients to avoid a particular food completely and adrenaline for their entire life”, one other oral immunotherapy.
Oral immunotherapy is time-consuming and involves significant logistical considerations. This toothpaste offers a less complicated option that families can incorporate into their every day routine, she said.
“I'm always looking for options like this,” Sokol said. “Of course, more studies need to be done. I really like the safety data on this. The fact that there are no cases of anaphylaxis is really important.”