US-based specialty biopharmaceutical company Allovate Therapeutics has reported positive results in a proof-of-concept study of oral mucosal immunotherapy (OMIT) using its main product Allerdent, which provides proteins including immunotherapeutic agents to the immune system while the user brushes their teeth.

Conducted at Weill Cornell Medicine, US, the study, titled ‘Oral mucosal immunotherapy for allergic rhinitis: A pilot study’, found that OMIT using Allerdent was safe and efficacious, similar to sublingual allergy immunotherapy (SLIT).

The open-label, non-randomised, 12-month prospective study included 24 participants with allergic rhinitis (AR) who chose to receive allergen-specific immunotherapy.

During the study, 12 participants received OMIT using Allerdent and 12 received under-the-tongue liquid SLIT drops.

“The open-label, non-randomised, 12-month prospective study included 24 participants with allergic rhinitis (AR) who chose to receive allergen-specific immunotherapy.”

OMIT uses a proprietary, specially formulated toothpaste to include and stabilise allergenic proteins that are administered while a user brushes their teeth, providing key agents to the areas of the oral cavity with the highest density of the immune cells responsible for initiating desensitisation.

Allovate stated that two participants dropped out of the OMIT arm and four dropped out of the SLIT arm, none from dissatisfaction with their treatment.

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In addition, no gastrointestinal events were reported by participants on the OMIT group, but worsening reflux and itching in the throat were reported among SLIT users.

However, none of the adverse events resulted in missed doses, and no lower airway or cardiovascular reactions were observed in either group.

Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores and Total Combined Scores (TCS) witnessed clinically significant improvements in both groups.

Overall adherence is described as successful administration of at least 90% of doses in patients who completed 12 months of the study, and was 80% in the OMIT group and 62% in the SLIT group.

Serum levels of allergen-specific IgG4, a vital biomarker for response to immunotherapy, increased within the first six months in both study groups.

OMIT patients with increased IgG4 levels reached peak levels more rapidly than SLIT patients, highlighting more rapid development of favourable immunological changes.

These blood markers provide objective evidence that OMIT has similar effects upon the immune system as the other approaches to allergy immunotherapy.

After the positive results, Allovate is currently in discussion with potential European, Latin American, and Japanese partners to develop OMIT platform products for airborne allergy patients in multiple global territories.

The company has also granted exclusive global rights to license the OMIT platform to treat food allergies to Intrommune Therapeutics.

Selected physicians and compounding pharmacies in the US are now offering Allerdent OMIT for airborne allergies.

The proof-of-concept research was supported by research grants from the US’ New York State Office of Science and Technology and Academic Research (NYSTAR), as well as the American Academy of Otolaryngic Allergy Foundation (AAOAF).