May 16, 2011
Meritage Pharma released results from a phase IIb trial of their proprietary oral budesonide suspension (OBS) for esophageal eosinophilia. This double-blind, randomized, placebo-controlled trial, PEER, enrolled 82 pediatrics ages two to 18 years who received low, medium or high dose OBS or placebo daily for 12 weeks. Treatment response was defined as subjects with <6 eosinophils (EOS) per high power field (HPF) in all esophageal levels and >50% symptom score reduction at the end of 12 weeks of treatment. Data are from 71 subjects who completed the treatment. At end of treatment, there were statistically significant greater percentages of responders in both the medium and high dose groups compared to placebo (52%, 47% and 5%, respectively). Subjects in the medium and high dose groups also demonstrated statistically significant histologic remission (<1 EOS per HPF) compared to placebo, as well as statistically significant reduction of endoscopic findings and epithelial inflammation. OBS was well tolerated.