NexEos Bio Announces Phase II of Clinical Trial for Lead Diagnostic

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MALVERN, PA., September 30, 2024  – NexEos Bio has initiated Phase II of its NDX-3315-1001 Clinical Trial for EoE, with the introduction of NDX-3324.

 

NDX-3324 is an oral, radiolabeled imaging agent for the detection, diagnosis and monitoring of Eosinophilic Esophagitis (EoE). NDX-3324 would be the first, non-invasive and visual imaging diagnostic for EoE and can identify active inflammation caused by proteins from degranulated eosinophils along the entire esophagus. The patient swallows NDX-3324 and then a single-photon emission computed tomography (SPECT) image is taken of the esophagus providing an image that shows if EoE is present, the degree of inflammation and the specific areas affected. 

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EoE is a chronic inflammatory condition of the esophagus affecting people of all ages – infants, children, and adults – and causes pain, dysphagia, and eventually esophageal strictures.  The current diagnostic standard for EoE is to identify the presence of >15 eosinophils per high-power field (HPF) through endoscopy plus biopsy.  However, the current standard is flawed as the presence of >15 eosinophils per HPF correlates poorly with symptoms of EoE and is sub-optimal for monitoring disease and treatment response.  Also, the patchy inflammatory involvement of EoE means that the biopsies may or may not be taken in areas that have inflammation, thus missing the diagnosis entirely or possibly under-estimating the level of disease severity.  This leads to the need for multiple, invasive, and expensive endoscopies with biopsies. For children, these procedures are performed under general anesthesia; for adults, conscious sedation is typically used. In either case, there are risks associated with these procedures.  The current standard of care is one of the reasons it takes 4-8 years on average to diagnose a patient with EoE.

 

Both physicians and patients are motivated to find a way to shorten the cycle to diagnose EoE, particularly now that several treatments have been approved for EoE and others are in late-stage development.

 

NexEos is dedicated to developing technologies to better diagnose and treat patients suffering from diseases caused by inflammation from eosinophil and cationic proteins, including NDX-3324 which is targeting Eosinophilic Esophagitis and has been granted Orphan Designation.

 

If you or someone you know is undergoing the process of diagnosis for  Eosinophilic Esophagitis, check out the ClinicalTrials.gov page for the second phase of our study here: https://clinicaltrials.gov/study/NCT05757856.

 

And to learn more about NDX-3324 and our entire pipeline which targets diseases driven by inflammation caused by eosinophil and cationic proteins, please visit  https://www.nexeosbio.com/technology for more information.