XenoPort’s randomized, parallel-group, double-blind, placebo-controlled Phase II clinical trial of XP19986 is designed to evaluate the efficacy, safety and tolerability of a sustained-release formulation of XP19986 (designated as SR3) in patients with symptomatic gastroesophageal reflux disease (GERD). The clinical trial is being conducted in approximately 150 patients at multiple study centers in the US. The primary endpoint of the GERD Phase II clinical trial is the difference in the total number of episodes of heartburn experienced by each subject over the entire treatment period for the combined XP19986 dose groups versus the placebo group.
XenoPort’s multiple-dose, randomized, placebo-controlled, crossover Phase II clinical trial of XP19986 is designed to evaluate the efficacy, safety and tolerability of a sustained-release formulation (designated as SR1) of XP19986 in patients with spasticity due to spinal cord injury. The Phase II clinical trial is being conducted at multiple study centers in the US. Three doses of XP19986 are being assessed in a randomized crossover comparison versus placebo. The primary outcome measure in this study is the Ashworth Scale assessment of muscle tone.
XenoPort’s randomized, double-blind, placebo-controlled single dose Phase I clinical trial is designed to assess the safety and pharmacokinetics (PK) of a prototype sustained-release formulation of XP21279 administered with carbidopa and to compare its PK profile to that of Sinemet (L-Dopa/carbidopa). Preliminary PK results are expected in the first quarter of 2008.
XP19986, a new chemical entity is a transported prodrug of R-baclofen and is designed to engage natural nutrient transport mechanisms found on intestinal cell membranes, thereby gaining efficient entrance into the bloodstream. XP21279 is a transported prodrug of levodopa, or L-Dopa, one of the most effective therapies for reducing symptoms associated with Parkinson’s disease.
XenoPort also confirmed plans to release top-line data from two Phase III clinical trials of XP13512 in patients with restless legs syndrome (RLS) in the first quarter of 2008. XenoPort also stated that GlaxoSmithKline, its partner for XP13512 in the US and other countries worldwide, excluding certain Asian countries, plans to file a new drug application for XP13512 for RLS with the FDA in the third quarter of 2008.