XenoPort, Inc. announced that it has initiated separate Phase 2 clinical trials of XP19986 in patients with gastroesophageal reflux disease, or GERD, and in spinal cord injury patients with spasticity.
In addition, XenoPort announced the initiation of the first clinical trial of XP21279, a drug candidate designed to treat Parkinson’s disease.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, “We are pleased to report these advancements in our XP19986 and XP21279 clinical development programs. Given our earlier positive results with single doses of XP19986 in GERD patients, we believe this new GERD clinical trial will enable us to identify effective doses of XP19986 when administered for one month. We will also be able to examine XP19986’s potential for once-a-day treatment of GERD patients.
The spasticity clinical trial will offer a first look at the potential of XP19986 to treat patients with spasticity associated with spinal cord injury. The XP21279 clinical trial in healthy subjects is designed to help us to understand if our Transported Prodrug of L-Dopa will enable a more optimal pharmacokinetic profile with the potential to avoid side effects and periods of ineffectiveness that are associated with current L-Dopa therapy.”
XenoPort also confirmed plans to release top-line data from two Phase 3 clinical trials of XP13512 in patients with restless legs syndrome, or RLS, in the first quarter of this year. XenoPort also stated that GlaxoSmithKline, or GSK, its partner for XP13512 in the U.S. and other countries worldwide, excluding certain Asian countries, plans to file a new drug application for XP13512 for RLS with the U.S. Food and Drug Administration in the third quarter of 2008.
GSK has stated that it also intends to initiate two polysomnography studies of XP13512 in RLS patients in the second half of 2008 to explore XP13512’s potential benefits in sleep.XenoPort also reiterated GSK’s plans to initiate additional clinical trials of XP13512 in other central nervous system related disorders. GSK has announced that it intends to initiate separate dose-ranging, Phase 2 clinical trials of XP13512 in post-herpetic neuralgia, or PHN, and painful diabetic neuropathy, as well as a Phase 2 clinical trial in PHN patients who have not responded to treatment with gabapentin, all in the first quarter of 2008.
In addition, GSK has announced that it expects to initiate, after discussion with the FDA, two pivotal dose-ranging efficacy studies and an open-label, long-term study of XP13512 for migraine prophylaxis in the second half of this year.