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Intrommune Therapeutics Completes Pre-IND Meeting With FDA on INT301 for Peanut Allergy
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September 06, 2018 07:11 ET | Source: Intrommune Therapeutics
New York, Sept. 06, 2018 (GLOBE NEWSWIRE) --
Intrommune Therapeutics, a New York-based biopharmaceutical company developing a patient-friendly immunotherapy platform for the treatment of food allergies, today announced that it recently participated in a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for the development of INT301 for the treatment of peanut allergy. INT301's unique formulation is designed to desensitize an individual with peanut allergy using a toothpaste delivery system, protecting them in the event of accidental ingestion. An estimated 15 million people in the United States have food allergies, and 3 million, including 1.5 million children, have peanut allergy.
"Following this highly constructive meeting with the FDA, we look forward to submitting our IND and moving into the clinic to evaluate the safety of INT301 for the treatment of peanut allergies," said Anthony Robinson, COO of Intrommune.
If approved, INT301 has the potential to be the first allergy immunotherapy treatment that easily integrates into a person's daily routine as a fully-functional toothpaste and both first-line and long-term maintenance therapy for peanut allergy.
Michael Nelson, Intrommune's CEO, added "Intrommune has a very innovative platform approach to treating allergies. We appreciate the thoughtful and productive meeting with the FDA regarding INT301 and we have incorporated all feedback into our clinical trial program to reduce risk and simplify our strategy. This should provide value to our stakeholders, including allergic individuals, their families, health care providers, the FDA, and the investment community."
An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational biological product to humans. The pre-IND meeting provided an opportunity for open dialogue between Intrommune and the FDA to review INT301, planned IND content, and the investigational plan for Intrommune's licensing application.
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 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. There is no FDA-approved treatment for peanut allergy or any other food allergy.
For more information, please visit www.intrommune.com.
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.
Michelle Mantia
Outreach Manager
Intrommune Therapeutics
mmantia@intrommune.com
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