Nov. 16, 2023 – A brand new toothpaste is displaying promise as a therapy to assist adults who’re allergic to peanuts tolerate rising quantities of peanut protein.
The investigational toothpaste is labeled INT301 and it met its security objectives in an early randomized, placebo-controlled trial.
Thirty-two adults, ages 18-55, who had been allergic to peanuts, had been enrolled within the 4-month trial. The individuals had been randomly positioned into teams that acquired both rising quantities of the peanut protein within the toothpaste to check how a lot they may tolerate safely or a placebo toothpaste that had no peanut proteins. The toothpaste was squeezed from a metered dispenser to manage the quantity.
Neither the individual giving the individuals the toothpaste, nor the affected person knew which sort of toothpaste they obtained, to assist remove potential bias.
“INT301 demonstrated security throughout all therapy teams,” mentioned the examine’s lead writer, William Berger, MD, an allergist and advisor for Intrommune, a biotechnology firm based mostly in New York Metropolis, which developed the toothpaste.
The toothpaste is a type of oral immunotherapy and it exposes the physique to an allergen in tiny however rising quantities over time to construct tolerance in case an individual is by chance uncovered to peanuts. Not like another oral immunotherapies, this one targets cells not just below the tongue, however in lots of components of the mouth with the best potential for allergy desensitization, Berger mentioned.
Berger offered the findings of the OMEGA (Oral Mucosal Escalation Purpose Evaluation) trial Nov. 11 on the American School of Allergy, Bronchial asthma and Immunology Annual Assembly in Anaheim, CA.
All Tolerated the Highest Dose
All individuals within the therapy arm constantly tolerated the very best dose. As well as, there have been no reasonable or extreme negative effects, Berger mentioned.
The primary response for many who obtained the therapy toothpaste was delicate itching contained in the mouth that might be eradicated with antihistamines.
Trial regulators had requested the investigators to look at for any dental negative effects and Berger mentioned the toothpaste didn’t trigger well being within the enamel or mouth.