Immunotherapy toothpaste shows promise for treatment of peanut allergy
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Key takeaways:
- INT301 is an oral mucosal immunotherapy that coats the oral cavity and desensitizes users to peanut.
- Analyses suggested patients had an immune response to treatment.
- The therapy was safe and adherence was high.
ANAHEIM, Calif. — Use of oral mucosal immunotherapy in the form of a toothpaste appeared safe and effective for the treatment of adults with peanut allergy, according to results of the placebo-controlled phase 1 OMEGA safety study.
The immunologic responses observed in the study, presented as a late-breaking abstract at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting, indicates the toothpaste (INT301, Intrommune Therapeutics) warrants additional research, according to William E. Berger, MD, MBA.
“INT301 is an investigational treatment that, unlike other treatments for people with peanut allergy, uses an innovative approach to peanut desensitization with oral mucosal immunotherapy (OMIT) in the form of a fully functioning toothpaste,” Berger, head of clinical development at Intrommune Therapeutics, told Healio. “INT301 was developed specifically to avoid the need for ingestion, which is associated with increased risk of adverse events, such as gastrointestinal and systemic reactions, including anaphylaxis.”
INT301 contains stabilized peanut allergenic proteins within a metered-dose dispenser that patients can use daily to brush their teeth. OMIT works by leveraging Langerhans cells in the oral cavity to reeducate the immune system and induce allergen desensitization.
“This is conveniently incorporated into patients’ routine of brushing their teeth, once daily,” Berger said. “The toothpaste allows the treatment to coat the entire oral cavity and gradually desensitize a patient to a specific allergen over time. Consistent exposure of the patient’s immune system to that specific allergen provides a new approach to allergy immunotherapy.”
The analysis included 32 adults aged 18 to 55 years with a positive skin prick test with a wheal of at least 3 mm, or with a peanut-specific IgE greater than 0.35 kU/L. Also, patients failed an oral food challenge of less than 100 mg of peanut protein at screening.
Notably, because this was a safety study, none of the patients had a history of severe anaphylaxis to peanut or severe asthma. Also, they did not have any planned dental surgery, nor were they on any biologic therapy or antihistamines.
Researchers randomly assigned patients 3:1 to receive escalating doses of INT301, up to 80 mg or 120 mg, or placebo. Seventeen of the patients also underwent maintenance dosing after the trial was extended up to 48 weeks based on safety demonstrated in the first study portion, some of whom also underwent a double-blind placebo-controlled OFC at the end of treatment to assess efficacy.
In terms of safety, all of the patients assigned INT301 were able to tolerate the treatment at the highest dose. There were no moderate or severe systemic reactions among patients assigned the toothpaste, and nonsystemic reactions were mostly mild and transient. Five of these in three patients required treatment, including two cases of abdominal pain, and one case each of pharyngeal, lip and gingival swelling that were all possibly or probably related to treatment.
Also, patients assigned the treatment used the toothpaste for 97% of the days.
“Based on previous medical literature, we were surprised by the high level of adherence and safety that was in contrast to the prior studies completed with other treatments for peanut food allergy,” Berger said. “We had no reported episodes of anaphylaxis nor severe adverse reactions, and no dropouts due to intolerance or dislike of the treatment, with an excellent 97% adherence rate.”
As an exploratory objective, researchers also evaluated changes in sIgG4 and found a significant increase in the treatment group compared with the placebo group (P = .046), as well as a decrease in the IgE/IgG4 ratio, both which indicate an immune response to treatment, Berger said during his presentation.
Also, all three patients who underwent a double-blind placebo-controlled OFC at the start and end of treatment from the INT301 group passed the 300 mg exit challenge, compared with one out of two patients in the placebo group. Researchers later determined this one placebo patient actually had oral food allergy syndrome, Berger said.
“Our study supports the advantages of OMIT over other approaches to allergy immunotherapy due to its targeted delivery and simplified administration, which supports the potential for improved safety, efficacy and adherence to treatment,” Berger told Healio.
Next year, researchers plan to initiate a larger phase 2 clinical trial focused on investigating the safety and efficacy of INT301 for the treatment of peanut food allergy in approximately 80 children.