Study Suggest Oral Mucosal Immunotherapy May Offer Safer, More Convenient Option

William E. Berger, MD

Credit: CHOC

The delivery of allergenic proteins through the use of a specialized toothpaste in Oral Mucosal Immunotherapy (OMIT) may represent a simplified and safer possibility among immunotherapy options, according to newly-announced findings presented by Intrommune Therapeutics, Inc.¹

The biotechnology firm presented this late-breaking poster at the 2024 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting held in Washington, DC. The results of the analysis the company presented suggest OMIT as a solid option for individuals with peanut or other allergies.

“At the present time, the only other approved oral product available to treat patients with peanut allergy requires extensive time and preparation to administer and is, unfortunately, associated with systemic side effects,” William E. Berger, MD, board-certified allergist and Intrommune consultant, said in a statement. “The addition of OMIT as a new, safe and convenient option for both patients and physicians, marks an important advancement in the treatment of food allergies. I look forward to the continued development of this therapeutic toothpaste.”

The OMEGA phase 1 clinical trial was a randomized, placebo-controlled, double-blind study in which 32 adult patients in the age range of 18-55 were recruited. These individuals had allergies to peanuts and were randomized in a 3:1 ratio to be given either placebo or an escalating dose of INT301.

Over the course of their research, the US Food and Drug Administration (FDA) had allowed amendments to the OMEGA Clinical Study protocol as a means to establish the maximally tolerated dose and to include a period of maintenance.

A substantial increase in IgG4 levels and a notable decrease in the IgE/IgG4 ratio was observed by the investigators. These results suggested an immunological response among study participants who had failed an oral food challenge (OFC) in the beginning to ≤100 mg of peanut protein and were now desensitized to ≥300 mg of peanut protein following OMIT.

At the conclusion of the team’s research, they identified a significant correlation that was observed between an Ara h 2 level ≥1.75 kU/L and a positive OFC during the study’s initiation. The investigators’ results indicate that OMIT could serve pediatric patients with allergies as a promising strategy for management of such allergies.

While there have been several substantial advancements made into the treatment of food allergies, the condition continues to be a major unmet challenge in the medical field. Allergies to food products are estimated to impact more than 220 million individuals around the world, and this includes about 33 million in the US alone.

Some of the options for patients with allergy that have recently come about include baked milk and baked egg immunotherapy, as well as epicutaneous immunotherapy options which expose tolerance-promoting immune cells through the use of an adhesive patch.

The currently-accepted strategy for management primarily involves avoidance of allergens which may trigger reactions. Despite this strategy, many allergens are found in different products so complete avoidance is challenging and the threat of anaphylaxis continues to pose an issue.¹

Despite notable immunotherapy success, the process is still dependent on consistent exposure to allergens so that the gradual desensitization of the patient occurs and, consequently, relies on adherence. OMIT may represent one more possibility for patients, and its targeted delivery system and administration simplicity may address concerns about adherence.

References

1. ^{Intrommune Therapeutics Presents Supporting Data Introducing a New Form of Food Allergy Treatment. Intrommune Therapeutics, Inc. February 22, 2024. https://www.globenewswire.com/news-release/2024/02/22/2833802/0/en/Intrommune-Therapeutics-Presents-Supporting-Data-Introducing-a-New-Form-of-Food-Allergy-Treatment.html. Date accessed: February 28, 2024.}
2. ^{Smith T. Oral Immunotherapy Shown to Be Effective in Desensitization for Egg, Milk, Peanut Allergy. HCPLive. July 6, 2023. https://www.hcplive.com/view/oral-immunotherapy-shown-effective-desensitization-for-egg-milk-peanut-allergy. Date accessed: February 28, 2024.}