Intrommune Therapeutics Supports Outcome of FDA Allergenic Product Advisory Committee Vote
The APAC recommendation is a clear validation of the role of immunotherapy in treating peanut allergies, said Michael Nelson, CEO, Intrommune.
New York, Sept. 16, 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, supports the outcome of the September 13, 2019 FDA Allergenic Product Advisory Committee’s (APAC) landmark recommendation to support the use of oral immunotherapy for peanut allergy treatment.
“The APAC recommendation is a clear validation of the role of immunotherapy in treating peanut allergies,” said Michael Nelson, CEO, Intrommune. “This is a significant advance for the entire food allergy community and we commend the APAC, the FDA, investigators and their staff, the food allergy advocacy community and, most importantly, the selfless individuals and their families who participate in clinical trials. The considerable efforts and risks taken by these stakeholders have significantly broadened our knowledge of food allergy immunotherapy.”
Unmet Need in Peanut Allergy
Food allergies represent an area of tremendous unmet medical need. There are currently no FDA approved treatments for any food allergy, including peanut allergies. Intrommune hopes that oral immunotherapy (OIT) will become a treatment option available to allergic individuals as soon as possible. Peanut allergic individuals and their families are desperate for FDA approved treatment options.
“The APAC recommendation opens the door for other immunotherapy treatments such as oral mucosal immunotherapy (OMIT), including peanut INT301, an allergy immunotherapy delivered in a fully-functional toothpaste,” said Erick Berglund, PhD, Chief Scientific Officer. “Peanut INT301 is the only product under development that enables regular and convenient extended use of allergy immunotherapy by integrating naturally into a person’s ordinary everyday routine of tooth brushing.”
“We look forward to advancing the field of peanut immunotherapy through our development of OMIT peanut INT301. Peanut INT301 is a developmental product we anticipate will deliver at least comparable efficacy compared to OIT, while minimizing systemic allergic reactions including anaphylaxis, treatment-induced epinephrine use, and risk of eosinophilic esophagitis. INT301’s expected product safety, efficacy profile and ease of use should make it an optimal peanut immunotherapy for most patients,” added Dr. Berglund.
“Intrommune is hopeful that its peanut INT301 product will offer additional options for peanut allergy patients,” added Mr. Nelson. “Further, we expect many of the approximately one out of five people that drop off of OIT due to adverse events and difficulty maintaining compliance to be able to easily integrate OMIT into their routines. Intrommune wants to make allergy immunotherapy accessible to all food allergic individuals, and ensure that desensitization is not only obtained, but also maintained.”
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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Michelle Mantia Outreach Manager Intrommune Therapeutics [email protected] John F. Kouten JFK Communications, Inc. 609-241-7352 [email protected]
