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XenoPort Announces Initiation of a Phase 2b Clinical Trial of Arbaclofen Placarbil in Patients with Gastroesophageal Reflux Disease

SANTA CLARA, Calif.--(BUSINESS WIRE)--Oct. 19, 2009-- XenoPort, Inc. (Nasdaq:XNPT) announced today that it has initiated a Phase 2b clinical trial of arbaclofen placarbil (AP), also known as XP19986, in patients with gastroesophageal reflux disease (GERD) who remain symptomatic despite treatment with a proton pump inhibitor (PPI). The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of AP as adjunctive therapy to PPIs.

Ronald W. Barrett, Ph.D., XenoPort’s chief executive officer, stated, “Based on the encouraging data in PPI-experienced patients from our previous monotherapy study and regulatory feedback regarding the path for approval of AP as adjunctive therapy, we are advancing our development program in GERD. Given its unique mechanism of action, we believe AP has the potential to provide symptomatic relief to GERD patients inadequately responding to PPIs.”

XenoPort expects to enroll approximately 425 subjects in this trial, which is being conducted in the United States and Canada. Subjects with a history of incomplete response to a PPI will undergo a four-week run-in on PPI therapy followed by a six-week treatment period on PPI therapy plus either 20 mg or 40 mg of AP dosed once daily, 20 mg or 30 mg of AP dosed twice daily or placebo. The primary endpoint of the study will examine heartburn events. Regurgitation will be assessed as a key secondary endpoint.

About XP19986

AP (arbaclofen placarbil) is a Transported Prodrug of R-baclofen that is designed to engage natural nutrient transport mechanisms found on intestinal cell membranes, thereby gaining efficient entrance into the bloodstream. AP is then rapidly converted by high-capacity enzymes to R-baclofen and natural substances that have well-studied, favorable safety characteristics.

R-baclofen is an agonist of a target known as the gamma amino-butyric acid(B), or GABA(B), receptor. Racemic baclofen (a mixture of R and S isomers) has been approved for the treatment of spasticity and has been shown in clinical studies to have efficacy in a number of other therapeutic indications, including GERD.

About GERD

GERD is a digestive system disorder affecting approximately 20% of the U.S. population. Common symptoms include heartburn and regurgitation. Current treatment of GERD primarily involves suppression of acid secretion through the use of antacids, PPIs and H2 receptor antagonists. PPIs are the most efficacious and commonly used therapy to treat GERD. While PPIs improve symptoms in the majority of GERD patients, it is estimated that up to 40% of patients on once-daily PPI therapy continue to experience breakthrough symptoms.

About XenoPort

XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body’s natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. XenoPort is developing its lead product candidate, XP13512, in collaboration with Astellas Pharma Inc. and GlaxoSmithKline (GSK). The U.S. Food and Drug Administration is currently reviewing GSK’s new drug application for XP13512 as a potential treatment for moderate-to-severe primary restless legs syndrome. XenoPort’s product candidates are also being studied for the potential treatment of GERD, migraine headaches, neuropathic pain, spasticity and Parkinson’s disease.

To learn more about XenoPort, please visit the web site at www.XenoPort.com.

Forward-Looking Statements

This press release contains “forward-looking” statements, including, without limitation, all statements related to our future clinical development program for AP and the timing thereof; the release of additional clinical trial data and the timing thereof; the therapeutic and commercial potential of AP; the suitability of AP as a treatment for GERD; and our future clinical trials and the timing thereof. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “expects,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon XenoPort's current expectations. Forward-looking statements involve risks and uncertainties. XenoPort's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the uncertain results of future clinical trials; XenoPort’s ability to successfully conduct future clinical trials for AP; the uncertainty of the FDA approval process and other regulatory requirements; and the uncertain therapeutic and commercial value of AP. These and other risk factors are discussed under the heading “Risk Factors” in XenoPort’s Quarterly Report on Form 10Q filed with the Securities and Exchange Commission on August 6, 2009. XenoPort expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

XenoPort is a registered trademark.

Source code: XNPT2C

Source: XenoPort, Inc.

XenoPort, Inc.
Jackie Cossmon, 408-616-7220

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