Toothpaste for peanut allergy clears early-phase trial

A fully functioning toothpaste specially formulated to mitigate allergic reactions to peanuts via oral mucosal exposure shows promise in terms of safety, according to data from the phase I OMEGA* study.

Called INT301, the toothpaste delivers allergenic peanut proteins to areas of the oral cavity with the greatest potential for allergy desensitization. The idea is to consistently expose the individual’s immune system by regularly brushing their teeth with the toothpaste, leading to gradual desensitization to the allergy trigger over time.

In the 48-week OMEGA study, 32 adult participants (18 to 55 years of age) with peanut allergy were randomly assigned to receive treatment with either INT301 (at an escalating dose) or placebo paste. Individuals with a history of severe anaphylaxis, severe dental problems, and severe asthma were excluded from the trial.

The study met its primary endpoint of safety, with INT301 demonstrating safety across all treatment groups, reported lead study researcher Dr William Berger of Children’s Hospital of Orange County in California, US, in a presentation at ACAAI 2023.

All participants who used INT301 consistently tolerated the highest dose specified in the protocol. There were no cases of moderate or severe systemic reactions during the study. [Berger, et al, ACAAI 2023]

Five mild adverse events, possibly associated with treatment, occurred in three participants. These included two cases of abdominal pain and single cases of pharyngeal, lip, and gingival swelling. Importantly, none of the participants developed any dental or oral cavity problems, Berger noted.

Adherence to treatment reached 97 percent with INT301 and 99 percent with placebo paste, with no dropouts due to the study medication.

In terms of efficacy, data from a small group of participants underwent a double-blind, placebo controlled, oral food challenge. At the end of the study, all participants who received INT301 were able to successfully ingest at least 300 mg of peanut protein (equivalent to 1–1.5 peanuts) as opposed to only 50 percent of those who received placebo.

Compared with the placebo group, the INT301A group showed a significant change in serum immunoglobulin (Ig)G4 levels (p=0.046) with a notable reduction in the IgE/IgG4, which Berger identified as a sign of immunologic activity.

“There are very few options available to patients with peanut allergy other than avoidance,” said Berger. “The only other approved product available at the present time requires extensive time and preparation to administer and is, unfortunately, associated with systemic side effects, including stomach pain and anaphylaxis.”

In light of the phase I OMEGA data, Berger believes that INT301A represents a safe and convenient option for adults with food allergies. The toothpaste fits seamlessly into the patients’ normal daily routine, which supports the potential for improved adherence.

According to the company who developed INT301A, the full dataset of OMEGA will be reported in 2024 with a phase II trial in a paediatric population already in the pipeline.

*Oral Mucosal Escalation Goal Assessment