Intrommune Therapeutics Announces Positive Results of Proof-of-Concept study of Oral Mucosal Immunotherapy (OMIT) Platform for the Treatment of Allergies

Patient-friendly platform treats allergies while a patient brushes their teeth

Oral mucosal route of administration demonstrated to be efficacious

No gastrointestinal side effects observed with OMIT

New York, April 25, 2016 (GLOBE NEWSWIRE) --  Intrommune Therapeutics, a specialty biopharmaceutical company developing a patient-friendly platform for the treatment of food allergies, today announced the publication of positive results of a proof-of-concept study of oral mucosal immunotherapy (OMIT) to treat allergic rhinitis, led by Dr. William Reisacher, Associate Professor of Otolaryngology at Weill Cornell Medicine  and an otolaryngologist at NewYork-Presbyterian in New York City.

The study, titled “Oral mucosal immunotherapy for allergic rhinitis: A pilot study,” was published in the journal Allergy & Rhinology. The study found that OMIT is safe and efficacious for the treatment of allergic rhinitis compared to standard-of-care sublingual immunotherapy (SLIT) drops for airborne allergies. The results suggest that OMIT has an improved side-effect profile compared to SLIT, causing no gastrointestinal or cardiovascular side effects. Importantly, the results also indicate that OMIT fosters higher adherence to treatment than SLIT. OMIT works while a person brushes their teeth with a specialized toothpaste, while SLIT requires users to apply and hold allergen extracts under the tongue.

Intrommune’s lead product, INT-301, leverages the OMIT platform for the treatment of peanut allergies. Peanut allergy is a potentially deadly disease which affects 1.5 million children at a cost of $6.25 billion per year to families in the United States. There is currently no treatment for this condition.

Michael Nelson, JD, Co-Founder and CEO of Intrommune Therapeutics, said, “This trial data allows us to move forward with the development of INT-301. The data shows that the OMIT platform works as a delivery vehicle for the treatment of allergies, a family of disorders with many manifestations but common underlying mechanisms. We look forward to a day when people with peanut allergies can easily and effectively treat their allergies while brushing their teeth.”

Dr. Reisacher, author of the recently published paper, said, “Peanut allergy is a potential deadly disease with personal significance to me, as a lifelong peanut allergy sufferer. Our findings demonstrate OMIT’s potential, which Intrommune will build upon with the hope of getting a new treatment into the hands of peanut-allergic individuals as soon as possible.” 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.

Intrommune has exclusive global rights to license the OMIT platform for the development of treatments for food allergies. In addition to INT-301 for peanut allergy, Intrommune will develop the OMIT platform to treat other common food allergies. Eight common foods (peanut, tree nut, milk, egg, wheat, fish, and shellfish) account for 90% of the food allergies in the US. 15 million Americans, including 6 million children, have one or more food allergies.

The innovative OMIT technology platform is expected to increase treatment efficacy and adherence while reducing side effects due to increased precision of treatment delivery. OMIT delivers biologically active compounds to the areas of the oral mucosa that have the highest likelihood of causing allergy desensitization via a specialized, proprietary toothpaste. This approach has received strong support from leading food allergy researchers.

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 Immunotherapy

Food allergies affect an estimated 15 million Americans, including 6 million children, and over 220 million people worldwide. Allergen-specific immunotherapy is the only treatment modality that targets the root cause of the disease, consistently exposing the allergy sufferer’s immune system to small amounts of allergen proteins to desensitize them to the allergens over time. There is currently no commercially-available allergy immunotherapy product for food allergies. Oral mucosal immunotherapy (OMIT) uses a specially formulated toothpaste to stabilize and deliver allergenic extracts to the areas of the oral cavity with the greatest potential for allergy desensitization. OMIT promises advantages over existing approaches to allergy immunotherapy due to its targeted delivery, simplified administration, and ease of long-term patient adherence.

About Intrommune Therapeutics

Intrommune is developing the revolutionary oral mucosal immunotherapy (OMIT) treatment platform for food allergies. Intrommune’s lead product, INT-301, is expected to be a safe, effective and convenient therapy for patients who suffer from peanut allergy. OMIT is designed to deliver proteins, such as immunotherapeutic agents, to the immune system while the user brushes their teeth. OMIT is a long-term, patient-friendly, disease-modifying solution for the 220 million people, including 9 million adults and 6 million children in the U.S., who suffer from this life-altering condition.


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