
The company’s lead diagnostic NDX-3324 is a novel, non-invasive imaging agent to assist in the detection, diagnosis, monitoring, and treatment management of EoE.
NDX-3324 has the potential to significantly improve upon the current standard of care - endoscopy with biopsy - 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 improve detection and 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.
A clear unmet need exists for a more accurate, non-invasive technique for diagnosis and management of EoE.
The patient takes NDX-3324 orally then is imaged by SPECT-CT scan.
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Areas of eosinophilic inflammation are highlighted by the imaging agent.
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Areas of greatest inflammation are shown in red.
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This not only identifies that the patient has eosinophil-driven inflammation, but it also shows precisely where throughout the entirety of the esophagus the inflammation exists.
CT Scan of Patient with EoE
Eosinophils are a type of white blood cell that play a role in the body’s immune system. Problems arise when a person has a higher-than-normal number of eosinophils in their blood and/or if eosinophils infiltrate organs and tissues. Currently EoE can only be diagnosed by biopsy of esophageal tissue obtained with observation via an endoscope, a camera attached to a flexible tube that is inserted into a patient’s throat. Endoscopies can be painful, time-consuming and inconclusive, and may carry some risks—all of which discourage patients from undergoing the procedure.
“If a patient swallows this proprietary imaging agent, X-ray-like images will reveal inflamed tissue in which eosinophil major basic protein is deposited.”
Dr. Jerry Gleich, professor of internal medicine and dermatology at The University of Utah and now NexEos Co-Founder & Chief Scientific Officer, discovered that eosinophils contain a major basic protein, a toxic substance that damages tissue where it is deposited after eosinophils release it, causing inflammation. He and his team have identified a compound that binds to this eosinophil major basic protein and can thus be used to image sites of inflammation in the esophagus.
“If a patient swallows this proprietary imaging agent, X-ray-like images will reveal inflamed tissue in which eosinophil major basic protein is deposited,”said Dr. Gleich. In addition to confirming that EoE is causing the pain, the image also will identify precisely where the affected tissue is in the esophagus, how much of the esophagus is affected and the level of severity of the disease.
Potential benefits to patients of NDX-3324:
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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
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Potential to be first non-invasive test to allow for detection and ongoing monitoring of disease in EoE patients
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. Once patients are diagnosed, they are then treated with either dietary elimination therapy or pharmacotherapy. Currently, the only means of monitoring disease status and response to treatment is via symptom monitoring and periodic repeat endoscopies with biopsies.
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-3324.
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-3324 addresses this issue as well by assessing the entirety of the esophagus.
Expanded Access
Expanded Access Policy for Investigational Medicines
As of January 13th, 2025, NexEos Bio has been granted Fast Track designation for NDX-3324.
An investigational product is a drug product that has not been approved by FDA. Expanded access refers to the use of an investigational product outside of a clinical trial in the setting of a serious and life-threatening illness where there are no other treatment options, potential patient benefit justifies the potential risks of treatment, and providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
NexEos Bio's Expanded Access policy:
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NexEos Bio is committed to advancing novel diagnostic approaches for EoE.
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NexEos Bio's position is that enrollment in a NexEos-sponsored clinical trial is the preferred route of access to our investigational drug products. Information about ongoing clinical trials is posted publicly at www.ClinicalTrials.gov.
None of NexEos Bio's investigational drug products are available for expanded access at this time.
For additional information please contact: expandedaccess@nexeosdx.com
This policy is subject to change at NexEos Bio's sole discretion and updates to the policy will be posted on this website.