Intrommune reports exploratory peanut tolerance data for OMIT
Intrommune Therapeutics has presented exploratory efficacy data from its OMEGA Phase 1 safety trial at the 2026 Eastern Allergy Conference, suggesting its toothpaste-based oral mucosal immunotherapy (OMIT) platform warrants investigation in larger, powered efficacy studies.
In a subset analysis of three adult participants who completed 48 weeks of treatment with INT301, all tolerated at least 600 mg of peanut protein at study exit, measured by double-blind, placebo-controlled food challenge. That threshold is equivalent to roughly two to two-and-a-half peanut kernels and represents a greater-than-50-fold increase from a baseline median eliciting dose of 12 mg. The company was explicit in its release that these are exploratory endpoints, intended to generate hypotheses rather than to support conclusions about clinical efficacy.
Chief executive Michael Nelson highlighted that the findings were generated in an adult population, a group that has historically responded less well to food allergy immunotherapy than children. He said the data, combined with previously disclosed exploratory IgG4 immunological findings, reinforced the case for advancing INT301 into larger trials.
The platform
INT301 is formulated as a functioning toothpaste, using what Intrommune describes as proprietary biochemical processes to stabilise and deliver peanut allergen proteins via the oral mucosa. The company argues this route may offer consistent, low-burden allergen exposure that supports immune desensitisation. Adherence is a well-documented problem with current subcutaneous and sublingual immunotherapy regimens, which require careful dose escalation, clinic visits, and sustained patient compliance over years.
Edmond Chan, head of allergy at the University of British Columbia's Department of Pediatrics and a named external collaborator, said the concept of integrating allergen delivery into routine tooth brushing was "elegantly simple and easily portable." Chan said he plans to run real-world studies of the OMIT approach, though no timeline or protocol was disclosed. Jeffrey Weiss, one of the OMEGA principal investigators, described the data as strongly justifying progression to adequately powered efficacy trials.
Market context
Food allergy immunotherapy is a commercially active but clinically challenging space. The only broadly approved product for peanut allergy in the United States is Aimmune's Palforzia, an oral immunotherapy powder approved by the FDA in 2020 for children and adolescents aged four to 17. Uptake has been limited by dosing complexity and the requirement for in-clinic observation during dose escalation. DBV Technologies has pursued an epicutaneous patch approach for peanut allergy, though its regulatory path has been lengthy. A toothpaste-based delivery format would, if validated in larger trials, represent a meaningfully differentiated administration model.
The OMEGA trial was a Phase 1 safety study and was not powered to detect efficacy signals. The exploratory subset reported here involved only three participants in the active arm, which limits any interpretation of clinical relevance. Investors and clinicians will look for a fully powered Phase 2 trial with pre-specified efficacy endpoints and a broader participant cohort before drawing firmer conclusions about INT301's potential. Intrommune did not announce a Phase 2 design or expected start date in its conference presentation.