Allovate Therapeutics Announces Positive Results of Proof-of-Concept Study of Oral Mucosal Immunotherapy (OMIT)

Oral mucosal route of administration efficacious for allergy immunotherapy
Patient-friendly toothpaste fits into everyday routine
No gastrointestinal side effects observed with OMIT
Indications of improved adherence suggest a solution to the “crisis of compliance” in allergy immunotherapy
New York, April 25, 2016 (GLOBE NEWSWIRE) — Allovate Therapeutics, a biopharmaceutical company focused on improving treatment for allergies, announced today that positive results of a proof-of-concept study of oral mucosal immunotherapy (OMIT) using Allerdent, conducted at Weill Cornell Medicine , were published in the journal Allergy & Rhinology. 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).
Dr. William Reisacher, Principal Investigator and Associate Professor of Otolaryngology at Weill Cornell Medicine and an otolaryngologist at NewYork-Presbyterian, says of the study, “Adherence to immunotherapy is the key to lasting results. The data suggests that OMIT may keep people consistently engaged in their treatment long enough to achieve real improvements. OMIT is a great new option for children and adults suffering from allergies.” Dr. Reisacher previously presented top-line results of the study at the Scientific Program of the American Academy of Otolaryngic Allergy (AAOA) Annual Scientific Meeting on September 25, 2015 in Dallas, TX.
Erick Berglund, PhD, CEO of Allovate, welcomed the study results, saying, “This is the first clinical data to support two key expected benefits of OMIT over allergy shots and sublingual liquid allergy drops: a more favorable side-effects profile and long-term, consistent adherence to immunotherapy. OMIT shows promise to be a safe and efficacious approach for allergic diseases.”
The open-label, non-randomized, 12-month prospective study involved 24 participants with allergic rhinitis (AR) who chose to receive allergen-specific immunotherapy. Twelve participants received OMIT using Allerdent® and 12 received under-the-tongue liquid SLIT drops. Two participants dropped out of the OMIT arm and four dropped out of the SLIT arm, none from dissatisfaction with their treatment. No gastrointestinal events were reported by participants on the OMIT group, but worsening reflux and itching in the throat were reported among SLIT users. 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) saw clinically meaningful improvements in both groups. Overall adherence was 80% in the OMIT group and 62% in the SLIT group. Adherence was defined as successful administration of at least 90% of doses in patients who completed 12 months of the study.
Serum levels of allergen-specific IgG4, an important biomarker for response to immunotherapy, rose within the first 6 months in both study groups. OMIT patients with increased IgG4 levels reached peak levels more quickly than SLIT patients, indicating more rapid development of favorable immunological changes. These blood markers offer objective evidence that OMIT has similar effects upon the immune system as other approaches to allergy immunotherapy.
Following these positive results, Allovate is in discussion with potential European, Latin American, and Japanese partners to develop OMIT platform products for airborne allergy patients in multiple global territories. In Brazil, a larger study will test the efficacy of OMIT using Allerdent for allergic rhinitis due to dust mite allergy beginning in early 2016. The company has also granted the exclusive, global rights to license the OMIT platform for the treatment of food allergies to Intrommune Therapeutics.
Select physicians and compounding pharmacies in the U.S. are currently offering Allerdent® oral mucosal immunotherapy (OMIT) for airborne allergies.
This research was supported by research grants from the New York State Office of Science, Technology and Academic Research (NYSTAR), Allovate Therapeutics, and the American Academy of Otolaryngic Allergy Foundation (AAOAF). Dr. Reisacher is a co-founder of and has an equity ownership in Allovate, and serves as an unpaid consultant to the company.
About Oral Mucosal Allergy Immunotherapy
Respiratory allergies affect at least 60 million people in the United States, resulting in 11.1 million visits to the doctor in 2010. Symptomatic treatment, at a global cost of over $25 billion yearly, keeps symptoms at bay temporarily but does not offer a long-term solution. Allergen-specific immunotherapy is the only treatment method that targets the root cause of the disease. Immunotherapy has traditionally been administered by injecting allergens into the skin (subcutaneous immunotherapy) or placing them under the tongue (sublingual immunotherapy). Oral mucosal immunotherapy (OMIT) uses a proprietary, specially formulated toothpaste to incorporate and stabilize allergenic proteins that are administered while a user brushes their teeth, delivering key agents to the areas of the oral cavity with the highest density of the immune cells responsible for initiating desensitization. OMIT simplifies long-term daily adherence to immunotherapy for patients, offering a potential solution to the “crisis of compliance” in allergy immunotherapy.
About Allovate Therapeutics
Allovate Therapeutics is a New York City-based specialty biopharmaceutical company founded in 2012 to improve allergy treatment for all patients. Allovate’s aim is to provide safe, effective, and convenient new options for allergy sufferers that deliver demonstrable improvements to therapeutic adherence and clinical outcomes over existing allergy treatment protocols. Allovate’s lead product, Allerdent®, is designed to deliver proteins, such as immunotherapeutic agents, to the immune system while the user brushes their teeth.

Danya Glabau
Director of Medical Affairs
Allovate Therapeutics
dglabau@allovate.com