Meritage Pharma Inc., a San Diego company with six employees, is initiating a Phase 2 clinical trial to evaluate oral budesonide suspension, or OBS, for treating adolescents and young adults with an allergic inflammatory condition of the esophagus.
The double-blind, placebo-controlled 16-week study being conducted at multiple U.S. clinical centers will enroll about 100 patients aged 12 to 25 with confirmed eosinophilic esophagitis, or EoE, a chronic disease that makes it difficult for children to eat food and for adults to swallow.
Meritage Pharma CEO Elaine Phillips said EoE has been diagnosed in approximately 150,000 people in the U.S., including 80,000 to 90,000 youths under age 18.
Phillips said the new Phase 2 study is focused on dysphagia, or difficulty swallowing, in contrast to a Phase 2 study completed in 2010 that met its primary endpoint while evaluating the effectiveness of treating symptoms such as abdominal pain, refusal to eat and vomiting among a younger population of patients ages 2 to 18.
Phillips said there are currently no approved pharmacological therapies on the market for EoE, although the disease can sometimes be managed by eliminating foods that cause the inflammation.
“But in cases where folks have multiple allergies that may not always be possible,” Phillips said.
The OBS technology is licensed from UC San Diego, which is one of the sites participating in this second Phase 2 clinical trial.
— Julie Gallant