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