Arbaclofen (AGI-006)
Preliminary results of a 64 patient exploratory Phase II trial of arbaclofen in functional dyspepsia were reported in February 2007. The results demonstrated a robust profile of beneficial effects on a range of dyspeptic symptoms but without a matching response in the primary endpoint of patient global impression. Functional dyspepsia continues to represent a difficult indication to translate drug activity into a global response. The recent sub-classification of functional dyspepsia in ROME III reflects this continuing difficulty and may offer a strategy for further development in this indication in the future.
Nonetheless, arbaclofen did demonstrate statistically significant improvements across a range of secondary endpoints in this trial, including patient global severity, bloating, nausea, condition specific Quality-of-Life (QOL) and rescue antacids use. Therefore AGI has determined that the profile of activity of arbaclofen in various dyspeptic symptoms matches well with the desired profile of a therapy for the dyspeptic symptoms of gastroparesis.
