FDA Grants Orphan Drug Designation to NexEos Bio’s Investigational Radioimaging Agent as a Diagnostic for the Management of Eosinophilic Esophagitis

 

 

 

WAYNE, Pa., April 10, 2020  – NexEos Bio, a privately-held medical diagnostics and therapeutics company dedicated to improving the detection, diagnosis, treatment and life-long management of patients living with chronic, eosinophil-related inflammatory diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NDX33-o as a diagnostic for the management of eosinophilic esophagitis (EoE).

 

“Individuals living with EoE suffer with symptoms and often go undiagnosed for far too long,” said Gerald Gleich, MD, Co-Founder and Chief Scientific Officer of NexEos Bio. “Orphan drug designation from the FDA reinforces the importance of our work to advance NDX33-o as a tool to streamline the diagnosis and management of patients suffering from EoE.  We look forward to advancing our clinical program in coordination with the FDA.”  

 

EoE is a chronic inflammatory condition of the esophagus affecting people of all ages – infants, children and adults – that causes pain, dysphagia (or difficulty swallowing) and eventually esophageal strictures. The current diagnostic standard for EoE is to identify the presence of greater than 15 eosinophils per high power microscopy field (HPF) on biopsy taken through endoscopy (EGD) where the patient is typically under conscious sedation or general anesthesia. EoE is a notoriously patchy condition that can be missed on biopsy, leading to misdiagnosis.  In addition, patients are often reluctant to undergo an endoscopy leading to significant delays in diagnosis for individuals of up to five or more years on average.  The aim of the NexEos program is to develop NDX33-o as the first non-invasive tool that images the entirety of the esophagus in patients with EoE.

 

The FDA’s Office of Orphan Products Development (OOPD) designates orphan status to drugs and biologics intended for the treatment of rare diseases or conditions that affect fewer than 200,000 people in the United States. The designation provides certain benefits to the drug developer including the potential for seven years of market exclusivity upon FDA approval, prescription drug user fee waivers and tax credits for qualified clinical trials.

 

About Eosinophilic Esophagitis (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) where the patient is typically under conscious sedation or general anesthesia. Once patients are diagnosed, they are then treated with either dietary elimination therapy or phamacotherapy. Currently, the only means of monitoring disease status and response to treatment is via symptom monitoring and periodic repeat endoscopies with biopsies.

 

 

About NexEos Bio

NexEos Bio is a privately held medical diagnostics and therapeutics company dedicated to improving the detection, diagnosis, treatment and life-long management of patients living with chronic, eosinophil-related inflammatory diseases. Through the licensing, development and commercialization of novel technologies, NexEos Bio is bringing new tools to market that address the unmet needs of patients suffering with eosinophil-related diseases. Our lead program, NDX33-o, is a novel, non-invasive imaging agent for the diagnosis, treatment monitoring, and management of Eosinophilic Esophagitis (EoE).