Intrommune Therapeutics is a New York City-based biopharmaceutical company developing a new, simple treatment for food allergies. The company’s toothpaste drug delivery platform offers an easy and safe way to retrain the immune system to reduce the risk of symptoms of food allergy, like throat swelling, stomach upset or even a life-threatening drop in blood pressure. Our first product candidate takes aim at peanut allergy. There is no FDA-approved treatment for peanut allergy or any other food allergy.
Food allergy is a serious and potentially life-threatening medical condition affecting 15 million people in the United States, including approximately 8% of children and 5% of adults. 17 million more deal with the condition in the European Union.
Food allergy reactions may vary unpredictably from mild to severe. Mild food allergy reactions may involve only a few hives or minor abdominal pain. Some food allergy reactions progress to severe systemic reactions, known as anaphylaxis. Anaphylaxis can lead to a drop in blood pressure, difficulty breathing, unconsciousness, and other life-threatening symptoms.
People with food allergies and their loved ones live in fear. Everyone affected is anxious for a solution.
Intrommune’s novel drug delivery platform is called oral mucosal immunotherapy, or OMIT. OMIT is based on the principle of allergy immunotherapy, a technique that allergists have used to treat the underlying cause of respiratory allergies for over a century. Allergy immunotherapy is a long-term treatment for allergies. Patients receive tiny, carefully controlled amounts of the substance they are allergic to, like pollen or peanut proteins. Over time, their immune system learns that the substance is safe and allergic reactions become milder.
Intrommune is developing this technology in accordance with FDA guidelines. It will be fully developed and tested for safety and efficacy to ensure the best results for food allergy patients.
OMIT uses the unique ability of the lining of the mouth to retrain the immune system and reduce allergic reactions to foods like peanuts over time. The toothpaste platform has been specially designed for optimal safety, efficacy, and tooth-brushing experience. The dose of medication (peanut-derived protein) in the toothpaste is designed to be low enough to be safe, yet sufficient to trigger the immune system’s desensitization process. Daily use of OMIT gradually increases the threshold of allergen that would normally trigger food allergy symptoms - to the point where an allergic person is protected against accidental ingestion of these foods. Research suggests that long-term, daily maintenance therapy is necessary to achieve and maintain this protection. Intrommune’s great-tasting, cavity-fighting toothpaste makes that easy to do.
In the United States, an estimated 15 million Americans have food allergies – 6 million children and 9 million adults. Food allergies are on the rise, with rates of peanut allergy tripling in children from 1997 to 2008.
Food allergies cause an estimated 200,000 hospital emergency room visits a year in the US. In 2013, food allergies had an estimated economic cost of $24.8 billion, or $4,184 per allergic child per year. Treating the underlying disease would save lives and significantly raise the quality of life of food allergy sufferers. It would also significantly reduce the total cost to healthcare systems.
Eight common foods – peanut, tree nut, wheat, milk, egg, soy, fish and shellfish – account for 90% of all food allergies. Peanut alone is responsible for up to 25% of childhood food allergies.
Although there are no therapies available yet, the global peanut allergy market is estimated to be worth ~$8 billion annually. There are two public biotechnology companies that are developing different approaches to peanut allergy immunotherapy for this market. These companies are each currently worth over $1 billion. Their product candidates are now in clinical trials and have not yet received FDA approval. Their value highlights the enormous unmet need for FDA-approved peanut allergy therapies.
People with peanut allergy must strictly avoid peanuts and all foods that may contain even trace amounts of peanut. Unfortunately, it is rare that avoidance is entirely successful. Thus, they must be prepared to treat an unexpected reaction at all times and in any setting. There are some medications to treat the symptoms of an allergic reaction, like antihistamines to treat hives or epinephrine auto-injectors to treat anaphylaxis. None of these medications treat the underlying condition, and patients who use epinephrine need to go to the emergency room immediately for further treatment.
OMIT is expected to have many advantages over other food allergy therapies under development by other companies. These include:
Minimized side effects due to limited exposure of allergens with the stomach and esophagus (connects the throat and stomach). Allergens are spit out with the OMIT toothpaste after two minutes of brushing.
Optimized efficacy due to two minutes of allergen contact with the entire interior of the oral cavity.
Combining daily administration with the daily habit of tooth brushing. It is expected to simplify long-term, adherent use of treatment, which in turn supports ongoing maintenance of food allergen tolerance.
No need to add an additional medication to the daily routine, such as skin patches. OMIT’s ease of use will help minimize an allergic person’s feeling of being sick or “not normal.”
2013 - 2018: Multiple clinical publications demonstrating sublingual drops delivered under the tongue, also known as SLIT, can be a safe and effective treatment for peanut allergy. SLIT is similar to OMIT in that it brings food allergens into regular, brief contact with oral tissues. These successful SLIT studies therefore provide compelling evidence that OMIT can treat peanut allergy patients.
December 2015: Intrommune Therapeutics established as a company.
December 2015: Intrommune Therapeutics licenses global rights to develop food allergy OMIT from Allovate Therapeutics.
January - May 2016 - Intrommune assembles scientific advisory board of accomplished academic research thought-leaders in clinical immunology, pediatrics, and food allergy.
March 2016 - Initial patent for OMIT for food allergies issued in the United States.
April 2016 - Publication of 12 month pilot study demonstrating OMIT safety and efficacy to be comparable to SLIT in reducing airborne allergy symptoms.
December 2016 - First patent for OMIT for food allergies issued in Japan.
January 2017 - Patent for OMIT for food allergies issued in Australia.
November 2017 - Second patent for OMIT for food allergies issued in Japan.
December 2017 - License agreement is amended.
2016 to 2018 - Pre-clinical and clinical trial protocols developed in conjunction with food allergy experts, patients and clinical trial experts.
May 2018 - Submitted Pre-IND Meeting Request to the U.S. FDA
July 2018 - Pre-IND Meeting Expected With the U.S. FDA
Intrommune Therapeutics’ official name is ZENII, LLC, so that’s the name that appears in the statements below. Since December 31, 2017, the date of the most recent balance sheet, Intrommune Therapeutics has completed an equity split of 1 Class A Unit into 150 Class A Units.
These financial statements have been reviewed by an independent Certified Public Accountant.
Independent Accountant’s Review Report
Financial Statements as of December 31, 2017 and 2016 and for the years then ended:
Statements of Operations
Statements of Changes in Members’ Equity (Deficit)
Statements of Cash Flows
Notes to Financial Statements
The Offering Statement is a formal description of the company and this transaction. It’s filed with the SEC to comply with the requirements of exemptions 4(a)(6) and 506(c) of the Securities Act of 1933. Similar information is sometimes offered in a Private Placement Memorandum for 506(c) offerings.
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