In preclinical and Phase I clinical studies, ETC-642 has been shown to
enhance cholesterol mobilization and increase HDL-cholesterol levels.
ANN ARBOR, Mich., June 30 /PRNewswire-FirstCall/ --
Esperion Therapeutics, Inc. (Nasdaq: ESPR), a biopharmaceutical company
focused on discovering and developing HDL-targeted therapies for the treatment
of cardiovascular disease, today announced the initiation of a multiple-dose,
multi-center clinical study of its ETC-642 (RLT Peptide) product candidate in
patients with existing cardiovascular disease.
The randomized, double-blind, placebo-controlled Phase I study will
evaluate ETC-642 at up to four dose levels. Up to 32 patients with stable
atherosclerosis will receive once-weekly intravenous infusions of ETC-642 or
placebo over the treatment period at multiple clinical sites. The primary
objective of this study is to assess various potential dosing levels and
regimens for ETC-642 while evaluating safety and tolerability. The study will
also examine the pharmacokinetics and lipid effects of selected dosing
regimens.
In preclinical and Phase I clinical studies, ETC-642 has been shown to
enhance cholesterol mobilization and increase HDL-cholesterol levels. An
initial Phase I single-dose study in patients with stable atherosclerosis was
completed in 2002. A second Phase I single-dose study of ETC-642 is
continuing to enroll patients with stable atherosclerosis to evaluate safety
and tolerability of ETC-642 at higher dose levels and to determine the maximum
tolerated dose.
"Through the optimization of both the peptide and phospholipid components
of ETC-642 to mimic the beneficial properties of HDL, we hope to demonstrate
enhanced reverse lipid transport," stated Roger S. Newton, Ph.D., President
and CEO of Esperion Therapeutics. "Results from this study will guide us in
better understanding the potential benefits of ETC-642 as a treatment for
patients with high-risk atherosclerosis, including acute coronary syndromes."
A complex of a 22-amino acid peptide and phospholipids, ETC-642 mimics the
biological properties of apolipoprotein A-I, the major protein in HDL, to
promote cholesterol removal from artery walls and other tissues and enhance
reverse lipid transport. ETC-642 is one of two product candidates being
developed by Esperion that mimics the beneficial properties of HDL. These two
HDL mimetics are part of a larger portfolio of product candidates in
development by Esperion for both the acute and chronic treatment of
cardiovascular disease.
Esperion Therapeutics
Esperion Therapeutics, Inc. discovers and develops pharmaceutical products
for the treatment of cardiovascular disease. Esperion intends to
commercialize a novel class of drugs that focuses on a new treatment approach
called "HDL Therapy," which is based on the Company's understanding of high-
density lipoprotein, or HDL, function. HDL is the primary facilitator of the
reverse lipid transport, or RLT, pathway by which excess cholesterol and other
lipids are removed from arteries and other tissues and are transported to the
liver for elimination from the body. Esperion's goal is to develop drugs that
exploit the beneficial functions of HDL within the RLT pathway. Esperion
currently has several product candidates under development for the treatment
of cardiovascular disease. Esperion is listed on the Nasdaq National Market
under the symbol "ESPR." For more information, visit http://www.esperion.com .
Safe Harbor Statement
The information contained in this press release includes "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements are often identified by words such
as "hope," "may," "believe," "anticipate," "plan," "expect," "intend,"
"assume," and similar expressions. Forward-looking statements speak only as
of the date of this press release, reflect management's current expectations
and involve certain factors, such as risks and uncertainties, which may cause
actual results to be far different from those suggested by the Company's
forward-looking statements. These factors include, but are not limited to,
risks associated with: management's ability to successfully execute its
business strategies, including entering into any strategic partnerships or
other transactions; the progress and cost of development of the Company's
product candidates; the extent and timing of market acceptance of new products
developed by the Company or its competitors; dependence on third parties to
conduct clinical trials for the Company's product candidates; the extent and
timing of regulatory approval, as desired or required, for the Company's
product candidates; the Company's dependence on licensing arrangements and
strategic relationships with third parties; clinical trials; manufacturing;
the Company's dependence on patents and proprietary rights; the procurement,
maintenance, enforcement and defense of the Company's patents and proprietary
rights; competitive conditions in the industry; business cycles affecting the
markets in which any of the Company's products may be sold; extraordinary
events and transactions; the timing and extent of the Company's financing
needs and the Company's access to funding, including through the equity
market; economic conditions generally or in various geographic areas. These
factors are discussed in more detail in the Company's filings with the
Securities and Exchange Commission. The Company does not intend to update any
of these factors or to publicly announce the results of any revisions to any
of these forward-looking statements other than as required under the federal
securities laws.
Company Frank Thomas
Contact: VP, Finance and Investor Relations
Esperion Therapeutics, Inc.
+1-734-222-1831
fthomas@esperion.com
Media Bill Berry
Contact: Berry & Company Public Relations
+1-212-253-8881
bberry@berrypr.com
SOURCE Esperion Therapeutics, Inc.
 back to top
Related links:
http://www.esperion.com
CONTACT:
Company Contact: Frank Thomas, VP, Finance
and Investor Relations of Esperion Therapeutics, Inc.,
+1-734-222-1831, fthomas@esperion.com ; or Media Contact: Bill
Berry of Berry & Company Public Relations, +1-212-253-8881,
bberry@berrypr.com
|
