OMIT (Oral Mucosal Immunotherapy) is a new approach to the management of food allergy demonstrating a robust immunologic response in treated subjects.
NEW YORK, Feb. 22, 2024 (GLOBE NEWSWIRE) — Intrommune Therapeutics, Inc., a biotechnology company committed to developing a patient-friendly treatment platform for people with peanut and other food allergies, announces data in a late-breaking poster presentation at this year’s American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting in Washington, D.C. supporting Oral Mucosal Immunotherapy (OMIT) as a potential new form of food allergy treatment. This data demonstrates that OMIT, an investigational treatment, which delivers allergenic proteins utilizing an innovative, specially formulated toothpaste, can safely be used to treat patients with food allergies in a more convenient way than food allergy therapies currently available. The poster presentation will take place Friday, February 23, from 3:15pm – 4:15pm EST.
The data shows that there was a statistically significant increase in IgG4 and a decrease in IgE/IgG4 ratio consistent with an immunologic response, in active patients who failed an Oral Food Challenge (OFC) to ≤100 mg of peanut protein at study entry, but could tolerate ≥300 mg of peanut protein at the end of study after treatment. Interestingly, there was a strong correlation between an Ara h 2 level (a peanut protein component) ≥1.75 kU/L and a positive OFC at study entry. The results of this study suggest OMIT as a new approach for the management of food allergy, providing a strong foundation for further research in the pediatric population.
“Other than avoidance, there are very few options available to patients with peanut and other food allergies,” said William E. Berger, MD, a board-certified allergist and consultant to Intrommune. “At the present time, the only other approved oral product available to treat patients with peanut allergy requires extensive time and preparation to administer and is, unfortunately, associated with systemic side effects. The addition of OMIT as a new, safe and convenient option for both patients and physicians, marks an important advancement in the treatment of food allergies. I look forward to the continued development of this therapeutic toothpaste.”
About the OMEGA Trial
was a randomized, double-blind, placebo-controlled study that enrolled 32 adults (ages 18-55) with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. The study groups were blinded to the investigator, patients, and sponsor. During the course of the trial, the United States Food and Drug Administration allowed amendments to the OMEGA Clinical Study protocol to determine the maximally tolerated dose and to allow the addition of a maintenance period which included a DBPCOFC at the end of the trial.
About Peanut and Other Food Allergies
Unfortunately, food allergy remains an area of tremendous unmet medical need, affecting more than 220 million people worldwide, including approximately 33 million people in the United States. Management of food allergies currently focuses on avoidance of exposure to triggering foods, though often such foods, including peanuts, are common ingredients in food products and therefore difficult to avoid. Many people with peanut allergy are accidentally exposed and experience potentially life-threatening reactions, including anaphylaxis.
About Oral Mucosal Immunotherapy™
Oral Mucosal Immunotherapy (OMIT) utilizes complex patented biochemical processes to stabilize and deliver allergenic proteins in a fully functional toothpaste. By simply brushing your teeth, the allergenic proteins are delivered to immunologically active areas of the oral cavity with the greatest potential for allergy desensitization. Success with allergy immunotherapy hinges on consistent exposure of a patient’s immune system to gradually “desensitize” the patient to the specific allergy trigger over time. OMIT presents advantages over other approaches to allergy immunotherapy due to its targeted delivery and simplified administration, which supports the potential for improved adherence.
About Intrommune Therapeutics
Intrommune, dedicated to improving and protecting the lives of people with food allergy, is developing the revolutionary oral mucosal immunotherapy (OMIT) treatment platform for food allergies. OMIT is a patient-friendly solution for over 220 million people worldwide, including 33 million people in the United States, who suffer from life-altering food allergies. Intrommune Therapeutic’s lead product, INT301, has completed its Phase 1 clinical trial. All Phase 1 results along with future studies are intended to support OMIT as being a safe, effective and convenient therapy for patients who suffer from peanut allergy.
For more information on Intrommune Therapeutics, please visit www.intrommune.com
Contact:
Stuart Loesch
Intrommune Therapeutics
(484) 942-0323
sloesch@intrommune.com
Jen Zoller
Green Room Communications
(973) 975-5421
jzoller@grcomms.com
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