The commencement of the phase III clinical trial triggers a milestone payment of $10 million from Astellas Pharma, XenoPort’s partner for developing and commercializing XP13512 in Japan and five other Asian countries.
XenoPort’s phase III clinical program is intended to provide safety and efficacy data to support the filing and approval of a new drug application for XP13512 as a treatment for RLS.
The initial phase III trial is a randomized, double-blind, placebo-controlled trial that is designed to evaluate the safety and efficacy of 1200 mg of XP13512 administered once a day for 12 weeks.
This trial is anticipated to enroll approximately 200 patients and is being conducted at multiple US sites. Top-line results from Study XP052 are expected in the first half of 2007.
“The commencement of our first phase III clinical trial is an important milestone for XenoPort,” said Dr Ronald Barrett, XenoPort’s CEO.