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news.US based Meritage Pharma has initiated a phase II clinical trial to evaluate oral budesonide suspension (OBS) to treat eosinophilic esophagitis (EoE), an allergic inflammatory condition of the esophagus both in adolescents and young adults.
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EoE is a chronic disease characterized by symptoms related to esophageal dysfunction and eosinophil-predominant inflammation.
The 16-week study will enroll about 100 patients at multiple US clinical centers to evaluate the results after treating them with OBS or placebo by performing biopsies of the esophagus to assess eosinophilic infiltration.
The trial will also use a symptom scoring tool to evaluate patients response to therapy.
Meritage Pharma CEO Elaine Phillips said Meritage will look forward to its ongoing collaboration with stakeholders from industry, academia, patient advocacy associations and the FDA to evaluate OBS as a potential therapy for EoE.
"Patients with EoE struggle for months or years to the initial diagnosis only to find there are no approved pharmacologic therapies,” Phillips added.
”We are eager to continue our clinical program to evaluate OBS to enable patients to thrive, despite their disease."
OBS is a proprietary viscous oral formulation of budesonide, which is designed to coat the esophagus where the drug can act locally.