XenoPort Announces Initiation of a Phase 2 Clinical Trial of XP23829 in Patients With Psoriasis

  XenoPort Announces Initiation of a Phase 2 Clinical Trial of XP23829 in
  Patients With Psoriasis

Business Wire

SANTA CLARA, Calif. -- June 23, 2014

XenoPort, Inc. (Nasdaq: XNPT) announced today that it has initiated a Phase 2
clinical trial of XP23829, its proprietary investigational next-generation
fumaric acid product candidate. The trial is a multi-center, randomized,
double-blind, placebo-controlled study designed to assess the efficacy and
safety of XP23829 as a potential treatment of patients with moderate-to-severe
chronic plaque-type psoriasis.

Richard Kim, M.D., XenoPort’s chief medical officer, stated, “We are excited
to take this next step in the advancement of the development of XP23829. From
this Phase 2 trial, we hope to further our understanding of the efficacy,
safety and tolerability of XP23829. In addition, the study is designed to
generate information on the effect of dose and treatment duration on potential
reduction in psoriatic lesions and modulation of sub-populations of blood
immune cells. Based on historical enrollment rates of psoriasis studies
conducted in the U.S., we expect top-line results of the trial in the third
quarter of 2015.”

XenoPort expects to enroll approximately 200 subjects in this trial, which is
being conducted in the United States. The study will include a screening and
washout phase of up to four weeks, a 12-week treatment phase and a four-week
post-treatment phase. Eligible study subjects will be randomized to placebo or
one of three treatment arms of XP23829: 400 mg or 800 mg once daily or 400 mg
twice daily. The primary endpoint of the study will examine the percent change
in Psoriasis Area and Severity Index (PASI) score from baseline at the end of
week 12. Secondary endpoints will include the proportion of subjects who
achieve a reduction of 75% or greater from baseline in PASI (PASI-75) score
and subjects who achieve a Static Physicians Global Assessment (sPGA) score of
“clear” or “almost clear.”

Ronald W. Barrett, Ph.D., XenoPort’s chief executive officer, further
commented, “Fumaric acid ester drugs have been previously shown to be
effective in psoriasis, although there are no products in the class that are
approved by the U.S. Food and Drug Administration (FDA) for this indication.
We believe that this trial will begin to define the distinguishing attributes
of XP23829 as a potential best-in-class drug. These attributes could
potentially include convenient once-a-day dosing, reduced flushing and
gastrointestinal side effects and possibly more rapid onset and increased
magnitude of efficacy. We believe that the results from this trial, if
positive, could allow advancement of XP23829 directly into Phase 3 studies as
a potential treatment for psoriasis. In addition, based on the strong
correlation of results in psoriasis and relapsing forms of multiple sclerosis
(MS) observed for other fumaric acid based drugs, we believe that this study
could also form a basis for moving XP23829 into Phase 3 studies as a potential
treatment for relapsing forms of MS.”

About XP23298

XP23829, an investigational drug discovered and currently under development by
XenoPort, is a fumaric acid ester compound that is a prodrug of monomethyl
fumarate (MMF). Fumaric acid ester compounds have shown immuno-modulatory and
neuroprotective effects in cell-based systems and preclinical models of
disease. The fumaric acid ester class of compounds includes TECFIDERA, which
was approved in March 2013 by the FDA for the treatment of patients with
relapsing forms of MS, and FUMADERM, which is approved and widely used in
Germany for the treatment of patients with psoriasis.

XP23829 is protected by a U.S. composition-of-matter patent currently has an
expiration date of 2029.

About XenoPort

XenoPort, Inc. is a biopharmaceutical company focused on developing and
commercializing a portfolio of internally discovered product candidates for
the potential treatment of neurological disorders. XenoPort is currently
commercializing HORIZANT^® (gabapentin enacarbil) Extended-Release Tablets in
the United States and developing its novel fumaric acid ester product
candidate, XP23829, as a potential treatment for patients with
moderate-to-severe chronic plaque-type psoriasis and/or relapsing forms of MS.
REGNITE^® (gabapentin enacarbil) Extended-Release Tablets is being marketed in
Japan by Astellas Pharma Inc. XenoPort’s product candidate, arbaclofen
placarbil, has been licensed to Reckitt Benckiser Pharmaceuticals Inc., who
plans to initially test arbaclofen placarbil for its ability to suppress
alcohol cravings, reduce alcohol intake and to possibly facilitate maintenance
of abstinence in alcohol dependent people. XenoPort's pipeline of product
candidates also includes a potential treatment for patients with Parkinson's
disease.

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

Forward-Looking Statements

This press release contains “forward-looking” statements, including, without
limitation, all statements related to advancing the development of XP23829;
the suitability of XP23829 as a potential treatment for moderate-to-severe
chronic plaque-type psoriasis and/or relapsing forms of MS; the potential for
XP23829 to be developed into a best-in-class drug; XenoPort’s belief regarding
potential distinguishing attributes of XP23829; expected enrollment in the
Phase 2 clinical trial of XP23829; XenoPort’s expectation that it will obtain
top-line results of the Phase 2 clinical trial of XP23829 in the third quarter
of 2015; XenoPort’s belief that the results of the Phase 2 clinical trial
could allow the advancement of, or form a basis for moving, XP23829 into Phase
3 studies; and the therapeutic and commercial potential of XP23829. 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,” “could,” “expect,” “hope,” “may,” “possibly,” “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, the difficulty and
uncertainty of pharmaceutical product development and the uncertain results
and timing of clinical trials and other studies, including the risk that
success in preclinical testing and early clinical trials do not ensure that
later clinical trials will be successful, and that the results of clinical
trials by other parties may not be indicative of the results in trials that
XenoPort may conduct; XenoPort’s ability to successfully advance XP23829
development and to conduct clinical trials in the anticipated timeframes, or
at all; the risk that the completion of clinical trials for XP23829 may be
delayed or terminated as a result of many factors, including delays in patient
enrollment; the risk that XenoPort’s belief regarding potential distinguishing
attributes of XP23829 may not be observed or validated in clinical testing;
that XP23829 will require significant additional clinical testing prior to any
possible regulatory approvals and failure could occur at any stage of its
development; the uncertainty of the FDA’s review process and other regulatory
requirements; the uncertainty of protecting and expanding XenoPort’s
intellectual property rights, including the risk that patent rights may not
provide XenoPort with sufficient protection against competitive products or
otherwise cover commercially valuable products or processes; XenoPort’s
dependence on potential future collaborative partners; the availability of
resources to develop XenoPort’s product candidates and to support XenoPort’s
operations; and the uncertain therapeutic and commercial value of XenoPort’s
product candidates. These and other risk factors are discussed under the
heading “Risk Factors” in XenoPort’s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2014 filed with the Securities and Exchange Commission
on May 9, 2014. 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.

HORIZANT, REGNITE and XENOPORT are registered trademarks of XenoPort, Inc.

Source code: XNPT2C

Contact:

XenoPort, Inc.
Jackie Cossmon, 408-616-7220
ir@XenoPort.com
 
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