774 Effect of mGluR5 Inhibition with ADX10059, On Day and Night Time Reflux and Clinical Symptoms, in Patients with Gastro-Esophageal Reflux Disease (GERD): A Proof of Concept Study

Abstract

in the number of postprandial reflux episodes at 5cm distal to the LES compared to placebo. The reductions at 5cm were significant at the 10% significance level (p=0.0961 and p= 0.0905 for capromorelin and ghrelin respectively). The high doses of capromorelin (20 mg) and ghrelin (5 pmol/kg/min) demonstrated significant reductions (39% and 47%, respectively) in the number of reflux events measured at 15 cm above the LES compared to placebo. These reductions were statistically significant at the 5% significance level (p= 0.042 and p=0.012, respectively). Increases in distal esophageal amplitude were observed on average for all active treatments during both saline and viscous swallows compared to placebo. For the high doses of capromorelin and ghrelin, the increases were statistically significant at the 1% level for saline swallows (p=0.006 and p=0.009, respectively). There were no serious adverse events. CONCLUSION:. The highest tested doses of capromorelin and human recombinant ghrelin had effects on reflux parameters and on esophageal physiology, at doses that appear to be well tolerated. Further studies are warranted to evaluate the role of capromorelin in the therapeutic armamenterium for GERD.