Xenoport (f/k/a XNPT)

[surf1944]

6:32AM Xenoport reports negative results from a Phase 2b Clinical Trial of arbaclofen placarbil in GERD; none of the AP doses showed statistically significant improvements over placebo in the analysis of the primary endpoint (XNPT) 6.67 : Co announces preliminary top-line results from a Phase 2b clinical trial of arbaclofen placarbil as adjunctive therapy in patients with gastroesophageal reflux disease who do not experience complete relief of GERD symptoms while being treated with proton pump inhibitors. None of the AP doses showed statistically significant improvements over placebo in the analysis of the primary endpoint. Analyses of key secondary endpoints did not yield consistent results when AP doses were compared to placebo. Percent change in weekly heartburn events was analyzed using a repeated measures ANCOVA model. At week six, subjects in the placebo group showed a mean percent reduction in heartburn events of 68%. Although there were trends for improvement over placebo in the AP dose groups, none of the comparisons to placebo reached statistical significance. AP was safe and generally well tolerated at all dose levels. Most reported adverse events were mild or moderate in severity. Co states "We are disappointed that AP failed to demonstrate clear efficacy over placebo in this trial. While we will continue to analyze the data, at this time, we do not believe the efficacy results of this study warrant our investment in further development for AP in GERD. We believe the AP safety profile observed in this study continues to support our planned Phase 3 development program for AP in patients with spasticity."