XenoPort Announces Initiation of a Phase 2 Clinical Trial of XP23829 in Patients With Psoriasis
June 23 2014 - 08:30AM
Business Wire
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
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
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