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ACAAI 2023: Novel Toothpaste May Provide New Mechanism for Allergy Immunotherapy
Phase 1 study shows oral mucosal immunotherapy safe, effective for desensitizing adults with peanut allergies
FRIDAY, Nov. 17, 2023 (HealthDay News) -- Oral mucosal immunotherapy (OMIT), delivered as a specially formulated toothpaste, appears to be a safe and convenient option for desensitizing adults with peanut allergies, according to a study presented at the annual meeting of the American College of Allergy, Asthma & Immunology, held from Nov. 9 to 13 in Anaheim, California.
“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,” William Berger, M.D., from Intrommune Therapeutics in New York City, told Elsevier’s PracticeUpdate. “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.”
Berger and colleagues conducted the phase 1 OMEGA trial, in which 32 adults (age 18 to 55 years) with peanut allergy were randomly assigned (3:1) to receive either an escalating dose of INT301 or placebo for 48 weeks. Participants were required to fail an oral food challenge of ≤100 mg of peanut protein. The researchers told Elsevier’s PracticeUpdate that the toothpaste was dispensed in a metered dose dispenser and incorporated into the participants’ daily routine of brushing their teeth once daily.
The researchers found that 100 percent of active individuals consistently tolerated the prespecified protocol highest dose, with no moderate or severe systemic reactions, meeting all primary and secondary safety end points. Adherence to treatment was high (97 percent), with no dropouts due to study medication. Nonsystemic, adverse reactions were mostly local, mild, and transient, including oral itching. In a subset of participants, exploratory biomarkers were consistent with an immunologic response to treatment.
“INT301 treatment was well-tolerated by adult trial participants with peanut allergy,” Berger told Elseier’s PracticeUpdate. “We plan to initiate a larger phase 2 clinical trial focused on validating the safety and efficacy of INT301 for the treatment of peanut food allergy in the pediatric population in 2024.”
Intrommune funded the study.
