Study ADX10059-204 is a double-blind, placebo-controlled, multi-center European Phase IIb trial in about 90 gastroesophageal reflux disease (GERD) patients known to respond well to proton pump inhibitors (PPI). There will be a two week baseline symptom evaluation period followed by two weeks of administration of ADX10059 120mg twice daily.
ADX10059 will be used as a monotherapy so patients in the study will not use PPIs or other acid suppressant therapy during the baseline and study treatment periods.
The primary endpoint is patient reported symptom control compared to baseline. Objective measures of the effects of ADX10059 on lower esophageal sphincter function and acid reflux events will be made in a subset of patients using esophageal manometry and pH impedance monitoring. Data from the study is expected to be reported in late 2009.
Charlotte Keywood, chief medical officer of Addex, said: “We have already observed significant efficacy with ADX10059 in two clinical studies in GERD. This Phase IIb study will allow us to assess the potential of ADX10059 as a stand alone treatment for clinical symptom control in GERD sufferers as well as further understand how ADX10059 works on lower esophageal sphincter function.”