Research Presentations at the 2021 Annual AAAAI Meeting Highlight Limitations of Current Food Allergy Treatments and Further Validates Intrommune Therapeutics’ Approach

Global Allergy Conference Amplifies Need for Safe and Effective Peanut Allergy Therapies

New York, New York, UNITED STATES


NEW YORK, March 12, 2021 (GLOBE NEWSWIRE) -- The clinical and scientific team of Intrommune Therapeutics, a New York-based clinical stage biotechnology company developing patient-friendly treatments for peanut and other food allergies, participated in the virtual 2021 annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) on February 26 - March 1. A number of notable AAAAI oral presentations, abstracts, and posters lend clinical validation to Intrommune’s food allergy treatment platform, while others underscore the persistent need for additional treatment options.

Edwin Kim, MD, UNC Chapel Hill, presented findings from his group’s investigational study1 of peanut allergic toddlers (1-4 yrs) with Sublingual Immunotherapy (SLIT), which is the daily placement under the tongue of liquid drops containing peanut protein. After a period of gradually increasing doses, children were treated with 4mg per day of liquid peanut protein for a total of 3 years. Treated subjects increased the threshold of peanut protein they could safely consume by over 30-fold (median of 4443 mg protein tolerated after treatment). Moreover, there was no need for epinephrine use with SLIT in this study. These results suggest that targeting the oral mucosa with SLIT is at least on par with previous studies of daily ingestion of powder peanut protein, an approach known as oral immunotherapy (OIT), while utilizing a lower, safer dosing protocol.

This important SLIT study demonstrates the high efficacy and safety that can be attained by targeting the oral cavity of food allergic toddlers when compared to oral immunotherapy. Similar to SLIT, Intrommune’s Oral Mucosal Immunotherapy (OMIT) toothpaste platform, INT301, targets only the tissues of the oral cavity. OMIT also avoids ingestion of peanut protein as the OMIT toothpaste is spit out after use which is expected to mitigate the side effects seen with OIT ingestion.

A poster presented at the meeting by Sara Patrawala, MD and colleagues from University of Rochester Medical Center, demonstrated the adoption difficulties of Palforzia™ (Nestlé Health Science), the only currently FDA-approved treatment for peanut allergy2. This OIT-based product was approved last year for children and adolescents suffering peanut allergy. The presentation collected information on 131 peanut allergy patients who were offered the treatment in their clinic. Eighty-two percent of those patients declined the therapy while only eleven pursued it. The most common reasons to decline were concerns over side effects and time commitment required for therapy. The dosage protocol for this product necessitates at least 12 physician visits over 6 months to reach maintenance dosing. An initial dose escalation is required on the first day of treatment requiring several hours in the physician's office.

Adverse events and the time and logistical commitments for OIT have been cited as potential hurdles, particularly considering children’s school schedules and work demands of the parents. The limited adoption observed by Patrawala and colleagues is an indicator of these features, and underscore the persistent unmet need among these patients for additional therapies that have safer and more convenient profiles.

Intrommune’s OMIT platform is expected to reach maintenance dosing within 2-4 months, with no extended dosing schedule on the first day of treatment. “AAAAI presentations help elucidate why peanut OIT treatments have not been well accepted. There is a need for new, convenient, safer and efficacious modalities, such as OMIT, capable of substantively mitigating the risk of adverse events and use of epinephrine as seen with OIT,” said Abhit Singh MD, VP Medical Affairs, Intrommune Therapeutics.

About Oral Mucosal Immunotherapy

Oral mucosal immunotherapy (OMIT) using a specially formulated toothpaste stabilizes and delivers 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 delivered while a person brushes their teeth 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 approximately 32 million 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.

For more information on Intrommune Therapeutics, please visit https://intrommune.com

Cautionary Statement Regarding Forward Looking Statements

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.

John F. Kouten
JFK Communications, Inc.
609-241-7352

jfkouten@jfkhealth.com

References:

1. Safety and efficacy of peanut sublingual immunotherapy in toddler-aged peanut-allergic children: Edwin Kim, MD MS FAAAAI, Univ. of North Carolina SOM, Journal of Allergy & Clinical Immunology, JACI, February 2021 Vol. 147 No. 2, 2807 L2.

2. Patrawala, S. (2021, February). Real World Adoption of FDA approved Peanut Oral Immunotherapy with Palforzia. Poster session presented at the annual meeting of the AAAAI.