Oral budesonide suspension: Phase IIb data

A double-blind, U.S. Phase IIb trial in 119 EoE patients ages 11-40 with documented problems swallowing food showed that OBS met the co-primary endpoints of reducing eosinophilic inflammation in biopsy samples from the esophagus (p<0.0001) and of improving dysphagia symptom score as measured by the patient-reported DSQ (p=0.0096) from baseline to week 16 vs. placebo. OBS also met the secondary endpoints of improving histopathologic score, endoscopic score and physician global impression of disease activity vs. placebo. OBS was well tolerated. The trial also includes an ongoing 24-week open-label extension. Meritage said it plans to request an end-of-Phase II meeting with FDA to discuss Phase III protocol design, including the use of the DSQ symptom scoring tool. The company said the time frame for starting a Phase III trial is not disclosed and will depend on reaching an agreement with FDA for the trial design and on financing. OBS had Orphan Drug designation in the U.S. for EoE. ...