Meritage Pharma has begun a Phase II trial of oral budesonide suspension (OBS) for adolescent and adult patients with Eosinophilic Esophagitis (EoE).
OBS is a proprietary viscous oral formulation of budesonide that is designed to coat the esophagus where the drug can act locally. It received FDA orphan drug status for the treatment of patients with EoE.
The double-blind, placebo-controlled study, being conducted at multiple US clinical centres that specialise in the treatment of patients with gastrointestinal diseases, will enrol about 100 patients aged 12 to 25 with confirmed EoE and documented problems swallowing food.
Meritage Pharma CEO Dr Elaine Phillips said patients with EoE struggle for months or years receive a diagnosis, only to find there are no approved treatments.
"We are eager to continue our clinical program to evaluate OBS to enable patients to thrive, despite their disease," Phillips said.
In the 16-week study, patients will be evaluated after treatment of OBS or placebo by performing biopsies of the esophagus to assess eosinophilic infiltration. A symptom-scoring tool will be used to evaluate patients' response to the therapy.
The initial 12-week Phase II placebo-controlled dose-ranging trial evaluating 71 paediatric patients met the primary endpoint of reduction of esophageal eosinophilia and improvement in clinical symptom score. OBS was well tolerated with no serious adverse events, the study reported.