Lead Program: NDX-3315
The company’s lead program (NDX-3315) is a novel, non-invasive imaging diagnostic to assist in the detection, diagnosis, monitoring and treatment management of EoE.
NDX-3315 has the potential to significantly improve upon the current standard of care, offering a non-invasive, reliable test to better identify and locate inflammation in the esophagus. The non-invasive nature of the test will help to promote improved diagnosis of the disease, reducing the time from symptom onset to disease diagnosis and treatment. Additionally, it will help provide a better means of ongoing disease monitoring in order to optimize therapies for effective management.
By comparison to the current standard of endoscopy with biopsies, NDX-3315 has the potential to offer patients a non-invasive and more comprehensive alternative to assess disease.
A clear unmet need exists for a more accurate, non-invasive technique for diagnosis and management of EoE.
EoE is a chronic inflammatory condition of the esophagus affecting people of all ages – infants, children and adults – and causes pain, dysphagia (or difficulty swallowing) and eventually esophageal strictures. EoE is often misdiagnosed as GERD (gastroesophageal reflux disease) or food avoidance and patients can go many years without obtaining a correct diagnosis. The current diagnostic standard for EoE is to identify the presence of >15 eosinophils per high power microscopy field (HPF) on biopsy taken through endoscopy (EGD). Once patients are diagnosed, they are then treated with either dietary elimination therapy or phamacotherapy. Currrently, the only means of monitoring disease status and response to treatment is via symptom monitoring and periodic repeat endoscopies with biopsies.
Potential benefits to patients of NDX-3315:
Non-invasive oral imaging agent that can be used with SPECT (single-photon emission computed tomography) with or without CT (computed tomography) to evaluate inflammation in eosinophilic esophagitis
Potential to be first non-invasive test to allow for detection and ongoing monitoring of disease in EoE patients
At present, the diagnosis and management of EoE requires endoscopies with biopsies that are invasive, resource intensive and often a barrier to diagnosis for a large proportion of patients. Patients often undergo at least one upper endoscopy per year plus multiple biopsies to assess disease activity and ongoing disease management. Currently, this is the only available tool to not only diagnose patients but also to evaluate the adequacy of disease control and therapeutic response to treatment. For children, these procedures are performed under general anesthesia, which carries risks. For adults, conscious sedation is typically used. Additionally, there is a risk of esophageal perforation for patients with longstanding inflammation who may have esophageal narrowing. These meaningful risks associated with these procedures could be eliminated with NexEos’s novel, non-invasive diagnostic test, NDX-3315.
An additional shortcoming of the current diagnostic standard of care of EGD and biopsy relates to the patchy nature of the disease itself. The patchy inflammatory involvement of EoE combined with a highly point specific measure such as a biopsy, means that the biopsies may or may not be taken in areas that have active inflammation, thus missing the diagnosis entirely or possibly under-estimating the level of disease severity. NDX-3315 addresses this issue as well by assessing the entirety of the esophagus.