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news.XenoPort has reported negative preliminary top-line results from a Phase 2b clinical trial evaluating arbaclofen placarbil (AP) as adjunctive therapy in patients with gastroesophageal reflux disease (GERD).
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The study results revealed that 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 demonstrate consistent results when AP doses were compared to placebo.
The randomised, double-blind, placebo-controlled Phase 2b clinical trial enrolled 460 patients who experienced GERD symptoms despite proton pump inhibitors (PPI) therapy.
The patients were randomised to receive a PPI plus placebo, or a PPI plus one of four AP dose regimens (20mg or 40mg of AP dosed once daily, or 20mg or30 mg of AP, dosed twice daily) for six weeks.
The trial was conducted at 58 sites in the US and Canada.
The primary efficacy endpoint was percent change from baseline in heartburn events per week with the primary analysis assessing percent change from baseline in heartburn events at week six.