New York, Sept. 05, 2019 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, a New York-based biotechnology company developing a patient-friendly immunotherapy platform for the treatment of peanut and other food allergies, is pleased to report recently published data validating Intrommune's unique approach to treating peanut and other food allergies. This research was conducted by researchers at the University of North Carolina School of Medicine and appears in the current issue of the Journal of Allergy and Clinical Immunology.
Edwin Kim, MD and his team used sublingual immunotherapy (SLIT) to treat peanut allergy in young peanut allergy sufferers by placing liquid drops containing two milligrams of peanut protein under the tongue once per day and holding for two minutes. This landmark study clearly demonstrates that SLIT delivers a clinically meaningful level of desensitization in children who are allergic to peanuts.
In this study, 3-5 years of continual SLIT therapy allowed 67% of participants (86% of study completers) to consume at least 750 mg of peanut protein during an oral food challenge, with no severe reactions requiring epinephrine. Compared to a recent phase 3, multinational study of peanut oral immunotherapy, "peanut SLIT provides near-comparable desensitization in children with peanut allergy" with a substantially improved safety profile.1
"This study provides further evidence that the oral cavity may be the optimal route for regular self-administration of food allergy immunotherapy," said Michael Nelson, CEO, Intrommune Therapeutics. "The highly promising efficacy and safety findings of the study provide compelling additional support to Intrommune's OMIT approach, which functions via a similar mechanism, yet is expected to have substantial advantages."
SLIT is a subset of oral mucosal immunotherapy (OMIT), a broader category of allergy desensitization that targets any or all areas of the oral mucosal tissues with allergenic proteins in order to reduce the body's overreaction to that substance. Current research suggests that allergy desensitization via OMIT is due to the abundance of immunologic cells, known as oral Langerhans cells, within the oral mucosal tissues. These specialized immune cells are in the highest density in the areas along the cheek (buccal mucosa) and between the cheek and gums (vestibular mucosa). SLIT mainly targets the tissue under the tongue, representing less than 10% of the entire oral mucosa that can be targeted by OMIT.
"Key advantages of OMIT compared to these exciting SLIT data results, are expected to include, but are not limited to, optimal adherence, access to a greater number of oral Langerhans cells, minimal swallowing of protein as children learn to spit out toothpaste from a young age and the ability to achieve a more effective dose than that which can be reached with liquid SLIT," added William Reisacher, MD, FACS, FAAOA, Senior Medical Advisor, Intrommune Therapeutics.
Intrommune's OMIT delivery platform uses a fully functional toothpaste that contains carefully controlled doses of peanut or other food proteins. Thus, OMIT toothpaste enables regular self-administration of food allergy immunotherapy while a person brushes their teeth. Intrommune's approach targets the entire oral cavity and is able to deliver higher doses of food proteins than liquid SLIT preparations. While research suggests that long-term, daily desensitization therapy is crucial to achieve and maintain food allergy desensitization, previous studies using SLIT for food desensitization have noted significant drop-out rates over the long term due to difficulties with adhering to the regimen. Intrommune's great-tasting, cavity-fighting toothpaste will make adhering to daily self-administration more reliable and convenient because it integrates naturally into the daily routine.
"The SLIT study represents a giant step forward in understanding the clinical utility of targeting the oral mucosa to protect allergic individuals against accidental exposure to life-threatening foods," said Erick Berglund, PhD, Chief Scientific Officer, Intrommune Therapeutics. "Intrommune will continue to build on such research progress in its own clinical trials with INT301, a patent-protected OMIT toothpaste for treating peanut allergy. The initial clinical trial for INT301 will be completed in 2020."
About Peanut and Other Food Allergies
Food allergies affect an estimated 220 million people, including 9 million adults and 6 million children in the U.S. Management of food allergies currently focuses on avoidance of exposure to triggering foods, though many such foods such as 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, each year. Unfortunately, there are no FDA-approved therapies for any food allergy, an area of tremendous unmet medical need.
About Oral Mucosal Immunotherapy
Oral mucosal immunotherapy (OMIT) uses a specially formulated toothpaste to stabilize and deliver allergenic proteins 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 promises advantages over other approaches to allergy immunotherapy due to its targeted delivery, simplified administration, and support of reliable, long-term 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 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 life-altering food allergies. Intrommune's lead product, INT301, is expected to be a safe, effective and convenient therapy for patients who suffer from peanut allergy.
The Keiretsu Forum, a global investment community of accredited angel investors, has engaged in a thorough diligence process with Intrommune and has issued a positive report. To access this report, please visit: http://www.intrommune.com/keiretsu-dd
For more information on Intrommune Therapeutics, please visit http://www.intrommune.com
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This release may contain "forward-looking statements." Forward-looking statements are identified by certain words or phrases such as "may," "will," "aim," "will likely result," "believe," "expect," "will continue," "anticipate," "estimate," "intend," "plan," "contemplate," "seek to," "future," "objective," "goal," "project," "should," "will pursue" and similar expressions or variations of such expressions. These forward-looking statements reflect the company's current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the company. The company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.
This release does not contain or constitute an offer to sell or a solicitation of any offer to buy securities in the United States or in any other jurisdiction.
Michelle Mantia Outreach Manager Intrommune Therapeutics mmantia@intrommune.com John F. Kouten JFK Communications, Inc. 609-241-7352 jfkouten@jfkhealth.com
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