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Meritage Pharma Initiates Phase 2b Clinical Trial of Oral Viscous Budesonide for Pediatric Patients With Eosinophilic Esophagitis
Date:1/22/2009

SAN DIEGO, Jan. 22 /PRNewswire/ -- Meritage Pharma, Inc. announced today that it has initiated a dose-ranging Phase 2b clinical trial to evaluate oral viscous budesonide (OVB) for the treatment of children and adolescents with eosinophilic esophagitis (EoE), an allergic inflammatory condition of the esophagus. EoE can cause difficulty in swallowing and heartburn, and in severe cases it can lead to food impaction (food getting stuck in the esophagus) and in children, a failure to thrive (poor growth or weight loss). The trial is being conducted at multiple U.S. clinical centers that specialize in the treatment of patients with gastrointestinal diseases.

EoE is an emerging disease that has only recently been classified as a separate condition. Most centers of excellence have seen a dramatic rise in the incidence and diagnosis of EoE over the last decade. EoE tends to be a chronic disease with persistent or relapsing symptoms. The disease occurs when eosinophils, a type of white blood cell involved in allergic reactions, infiltrate the surface of the esophagus. This eosinophil infiltration leads to inflammation of the esophagus and is believed to cause the symptoms of EoE. A variety of stimuli may trigger this allergic process including certain foods and environmental allergens. People with EoE commonly have other allergic conditions such as asthma or eczema.

Symptoms of EoE may include nausea, dysphagia (problems swallowing), vomiting, stomach pain, chest pain, heartburn, loss of weight, and food impaction. Other symptoms may include reflux that does not respond to proton pump inhibitor therapy, failure to thrive, poor appetite, malnutrition and difficulty sleeping.

The double-blind, randomized, placebo-controlled 12-week study in up to 80 patients with confirmed EoE aged two to 18 is designed to evaluate three different doses of OVB. Patients will be evaluated by performing biopsies of the esophagus obtain
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SOURCE Meritage Pharma, Inc.
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