In late April, Xenoport/NASDAQ: XNPT shares jumped 44% as the company announced top-line results from its XP052 study, a Phase III clinical trial of XP13512 for the treatment of symptoms of primary restless leg syndrome (RLS). The company said the drug candidate demonstrated statistically significant improvements compared to placebo on both of the co-primary endpoints of the trial. The release of data from two additional Phase III studies, XP053 and XP060, is expected in the second half of 2007. The XP053 study is a short term study (12 weeks) and XP060 is a long term study (24 weeks). The three Phase III RLS studies are designed to demonstrate a statistically significant difference between the changes of treatment effects in the Phase IIb study compared to the Phase III studies. Other events in the RLS space include the potential FDA approval of an extended-release version of Requip in the second half of 2007. The immediate-release version of Requip will go off-patent in May 2008, so GlaxoSmithKline’s (NYSE: GSK) near-term strategy is to convert patients from the immediate-release version to the extended-release version prior to the introduction of generic versions of Requip. For neuropathic pain, GSK is planning to conduct Phase II studies in postherpetic neuralgia and diabetic neuropathy; these studies could begin later this year.
Other drug candidates in Xenoport’s pipeline include is XP19986. XenoPort is currently evaluating XP19986 as a potential once-daily formulation for gastroesophageal reflux disease, and a Phase II study for this formulation could begin by late 2007. The company is also looking to test XP19986 in muscle spasticity. XenoPort also is planning to file an IND later this year for XP21279, and should begin a Phase I study as a therapy for Parkinson’s disease later this year.
With pending news, we think Xenoport shares can continue its positive momentum.
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