Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease of the esophagus, characterized by eosinophilinfiltration into the esophagus, resulting in pain, dysphagia and, if untreated, eventual esophageal fibrosis andstricture. EoE prevalence in the U.S. is approximately 57/100,000 including patients of all ages, and currentevidence suggests that the overall prevalence of EoE continues to increase.. There is a great unmet medicalneed for a new EoE diagnostic method. The current standard-of-care method involves endoscopy plus biopsiesof the esophagus which are difficult, costly, and invasive, creating barriers to both diagnosis and ongoing diseasemanagement. As a result, EoE tends to be underdiagnosed and patients' symptoms and disease less optimallymanaged.NDX33-o is a novel, non-invasive medical imaging agent that is optimal for identifying eosinophilic inflammationin EoE patients and can be used to image and diagnose patients with EoE in a less invasive manner and with ahigher accuracy than today's current approach. Preliminary clinical results, in a limited number of patients haveshown that NDX33-o can detect areas of inflammation in esophagi of EoE patients supporting NDX33-o as anovel detection method for EoE.This project will assess NDX33-o detection of EoE in a larger number of EoE patients. Phase 1 of the projectwill focus on planning activities for the clinical trial that will be conducted in phase 2. In Phase 1, NexEosDiagnostics, Inc. will complete all planning activities including development of manufacturing methods for aNDX33-o kit for use in the radiopharmacy. NexEos will also seek IND approval from the FDA for theadministration of NDX33-o to human participants in the Phase 2 clinical study.After receiving IND approval, Phase 2 of the project will be initiated with a clinical study of 180 patients sufferingfrom EoE symptoms or dysphagia who will be enrolled at the University of Utah. All participants will receive thesame treatment - they will first be diagnosed by oral administration of NDX33-o and medical imaging followedseveral days later, by diagnosis with the current standard-of-care, endoscopy and biopsy.NDX33-o will be evaluated for its accuracy and sensitivity for detecting EoE compared to standard-of-care.Moreover, the safety profile of NDX33-o will be evaluated in all administered patients.Successful completion of the proposed clinical trial will significantly contribute to the development of NDX33-oas an imaging marker for eosinophil-related inflammation in EoE patients, and subsequently for the potentialdiagnosis of other human eosinophil-associated diseases.
Public Health Relevance Statement: NARRATIVE
Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease of the esophagus affecting approximately
150,000 children and adults, and is characterized by eosinophil infiltration into the esophagus, resulting in pain,
dysphagia and eventual esophageal strictures. The current diagnostic method involves endoscopy and biopsies
of the esophagus which are difficult, costly, and invasive, creating barriers to both diagnosis and ongoing disease
management and resulting in underdiagnosis of EoE. NexEos Diagnostics, Inc. is developing a novel, non-
invasive medical imaging agent that is optimal for identifying eosinophilic inflammation in EoE patients and can
be used to image and diagnose patients with EoE in a less invasive manner and with a higher accuracy than
today's current approach.
Project Terms: <21+ years old><0-11 years old>
