BioCentury
ARTICLE | Clinical News

Arbaclofen placarbil: Preliminary Phase IIb data

March 28, 2011 7:00 AM UTC

XenoPort discontinued development of arbaclofen placarbil to treat GERD after top-line data from a double-blind, North American Phase IIb trial in 460 patients who remained symptomatic despite PPI treatment showed that all doses of the compound as an adjunct to a PPI missed the primary endpoint of significantly reducing weekly heartburn events from baseline to week 6 vs. placebo plus a PPI. The company said that twice-daily 30 mg arbaclofen placarbil produced the largest reduction in weekly heartburn events from baseline to week 6 vs. placebo (78% vs. 68%, p=0.077). Additionally, XenoPort said that analyses of the trial's secondary endpoints, including regurgitation events, did not yield a clear and consistent pattern of benefit for arbaclofen placarbil over placebo. Based on the results, the company said it does not believe further investment in the compound to treat GERD is warranted. However, XenoPort said the safety profile of the compound continues to support a planned Phase III trial of arbaclofen placarbil to treat spasticity in multiple sclerosis (MS) patients, which is expected to begin this half. ...