XenoPort, Inc. (Nasdaq:XNPT) announced today that new data from its first clinical trial of XP21279, a Transported Prodrug of L-Dopa, in Parkinson's disease patients will be presented at the upcoming World Parkinson Congress meeting in Glasgow, Scotland.
Data to be presented at the Congress from XenoPort's four-week, Phase 1b, open-label, crossover clinical trial that evaluated ten Parkinson's disease patients with motor fluctuations show that XP21279 (administered with carbidopa) provided a statistically significant reduction in variability of L-Dopa concentration, based on mean absolute percent deviation from average concentrations of L-Dopa, compared to immediate-release Sinemet (L-Dopa/carbidopa) (p<0.05). In addition, compared to Sinemet, treatment with XP21279/carbidopa led to a reduction in average daily "off" time of 2.9 hours per day and an increase in average daily "on" time without troublesome dyskinesia of 2.4 hours per day. The mean time to "on" after the first morning dose of XP21279/carbidopa was 0.95 hour, compared to 0.97 hour for Sinemet. All treatment-emergent adverse events were mild to moderate in intensity.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, "This was an exploratory study in Parkinson's disease patients to see if XP21279 could provide an improved pharmacokinetic (PK) profile compared to Sinemet, one of the most widely used L-Dopa treatments for Parkinson's disease. We were pleased with the PK results of this study, and while we are cautious in interpreting the improvements in symptoms seen in the trial due its open-label design, the efficacy results were sufficiently encouraging to support our initiation earlier this quarter of a double-blind Phase 2 trial comparing XP21279 to Sinemet. We believe that positive results from the Phase 2 trial could support Phase 3 development of XP21279, with the ultimate goal of providing an improved dopamine replacement therapy for those Parkinson's patients who continue to suffer from motor fluctuations while taking currently available oral medicines."