ANAHEIM, California — A specially formulated toothpaste (INT301, Intrommune Therapeutics) met its safety endpoints as an oral immunotherapy to help adults with peanut allergy reduce their reaction risk, according to findings of a phase 1 study.
The 48-week, randomized, double-blind, placebo-controlled trial enrolled 32 adults aged 18–55 with peanut allergy to receive in a 3:1 ratio either an escalating dose of INT301 (a preset metered dose of formulated toothpaste containing peanut protein) or placebo paste.
The primary endpoint was safety, measured by the percentage of participants who could consistently tolerate the highest dose specified in the protocol and by the incidence of systemic and nonsystemic adverse reactions.
“INT301 demonstrated safety across all treatment groups,” said the study’s lead author, William Berger, MD, MBA, an allergist and consultant for Intrommune, a biotechnology company based in New York City.
Berger presented findings of the OMEGA (Oral Mucosal Escalation Goal Assessment) trial on November 11 in a late-breaking abstract session at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting.
All Tolerated the Highest Dose
Study participants had to undergo skin prick testing that demonstrated a minimum wheal diameter of 3 mm greater than control and/or a peanut-specific IgE level of at least 0.35 kU/L. Additionally, participants had to have failed an oral food challenge of 100 mg or less of peanut protein.
Patients who were extremely sensitive to peanut protein or who had severe dental problems or severe asthma were among those excluded, Berger said.
All participants in the treatment arm consistently tolerated the highest dose. No moderate or severe systemic reactions were seen in the treatment group. The main nonsystemic adverse reaction was oral itching, which was mild and transient, the data show. Treatment adherence was high (97%), and there were no dropouts because of the study medication.
“There were no dental or oral cavity problems,” Berger added.
The novel toothpaste is designed to deliver the therapy in several steps while brushing teeth in the traditional manner, he explained. Once the toothpaste enters the mouth, the proteins bind to mucosa. Langerhans cells then pull the protein into the lymph system. The Langerhans cells trigger reeducation of the immune system, and differentiated T cells help desensitize the patient.
The toothpaste “leverages the Langerhans cells in the entire oral cavity, not just under the tongue but on the palate, on the mouth and the buccal mucosa,” said Berger.
Signs of Efficacy in Blood Tests
Though this was primarily a safety trial, efficacy signals were evident in the exploratory blood test results, Berger reported.
Participants in the treatment arm demonstrated a significant increase in sIgG4 (serum immunoglobulin G4) levels relative to control participants (P = .046). Additionally, a decrease in the IgE/IgG4 ratio among active participants was indicative of an immunologic response to treatment with INT301, the data show.
Kristin Sokol, MD, MPH, an allergist/immunologist with Schreiber Allergy in Rockville, Maryland, who was not part of the study, told Medscape Medical News, “As of now, the only options we have for food allergy treatment and management are to tell our patients to completely avoid a food and carry epinephrine for their entire lives, or we have the option of offering oral immunotherapy in the form of Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] or an individualized oral immunotherapy program.”
Oral immunotherapy is time consuming, and there are substantial logistic considerations. This toothpaste offers an easier option that families can fit into their daily schedules, she said.
“I’m always looking for options like that,” Sokol said. “Obviously there are more studies that need to be done. I really like the safety data on this. The zero incidence of anaphylaxis is really important.”
The protocol for teeth brushing includes having patients perform the first brushing during an office visit to ensure there’s no reaction, Berger told Medscape Medical News. “Then [we] have them come back every 2 weeks as we increase the dose. Once they reach the top dose, they won’t have to come in very often. They’ll be on maintenance, so they may have to come in once every month or two at the most.” After a year, patients likely will have to come in only once every 4-6 months, he said.
Michael Nelson, CEO of Intrommune Therapeutics, described next steps for the investigational toothpaste in a press release: “We expect the full dataset of this trial to be reported next year and are focused on carefully designing a phase 2 trial to investigate the efficacy of INT301 in a pediatric study.”
The trial was sponsored by Intrommune. Berger is a paid consultant for Intrommune. Sokol has disclosed no relevant financial relationships.
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on X (formerly known as Twitter) at @MLfrellick
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