ANN ARBOR, Mich., Dec. 12 /PRNewswire-FirstCall/ --
Esperion Therapeutics, Inc. (Nasdaq: ESPR), a biopharmaceutical company
focused on discovering and developing HDL-targeted therapies, today announced
the initiation of a multiple-dose, multi-center Phase II clinical trial of its
LUV (large unilamellar vesicles) product candidate (ETC-588). ETC-588 is one
of the Company's investigational therapies in development for the treatment of
patients with Acute Coronary Syndromes (ACS).
The randomized, double-blind, placebo-controlled study will evaluate
ETC-588 at two dose levels. ETC-588 will be administered to patients in
intravenous infusions once-weekly over an eight-week period. The primary
objective of this Phase II trial is to determine the safety and tolerability
of ETC-588 in patients with ACS. In addition, as part of adverse event
monitoring, cardiovascular event data will be collected.
The study will evaluate up to one hundred and fifty patients who have been
hospitalized for ACS. The trial is being conducted at approximately
twenty-five sites nationwide.
Previous clinical studies indicate ETC-588 rapidly mobilizes cholesterol.
Another Phase II study of ETC-588 is continuing to enroll patients with
established vascular disease to measure changes in carotid plaque volume.
Results are expected in 2003.
"This new study marks a critical step in the development of our most
advanced product candidate. It is the largest trial to date for any of
Esperion's HDL therapies, and it is the first opportunity for ETC-588 to be
evaluated in ACS patients, its initial target population," stated Dr. Roger S.
Newton, President and CEO of Esperion. "We hope that this trial will provide
further evidence that ETC-588 is safe and well-tolerated and is a rapidly
acting, novel, short-term therapy that enhances the body's naturally occurring
processes to remove excess lipids from the body. This, in turn, may help to
stabilize vulnerable plaque and may reduce the risk of further cardiovascular
events."
ETC-588
ETC-588 is made of naturally occurring lipids that circulate through
arteries to facilitate the role of high-density lipoprotein (HDL) in removing
accumulated cholesterol and other lipids from cells including those in the
arterial wall. LUV are believed to be capable of transporting excess
cholesterol from the vasculature to the liver for eventual elimination as part
of the reverse lipid transport (RLT) pathway. Third party preclinical studies
with LUV have demonstrated regression of atherosclerosis. Esperion is
currently developing ETC-588 as a treatment for patients with high risk
atherosclerosis, including acute coronary syndromes.
Esperion Therapeutics
Esperion Therapeutics, Inc. discovers and develops pharmaceutical products
for the treatment of cardiovascular and metabolic diseases. 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 and metabolic diseases. Esperion is
listed on the Nasdaq National Market under the symbol "ESPR."
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; the progress and cost of development of the Company's
product candidates; the extent and timing of market acceptance of the
Company's product candidates; dependence on third parties to conduct clinical
trials for these 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 the
Company's products may be sold; extraordinary events and transactions; the
timing and extent of the Company's financing needs; economic conditions
generally or in various geographic areas; and other factors. 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
law.
CONTACT:
Esperion Therapeutics, Inc. JFCI (Media)
Frank Thomas Jacqueline Franchetti
Vice President, Finance and (516) 365-2091
Investor Relations (734) 222-1831
SOURCE Esperion Therapeutics, Inc.
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Related links:
http://www.esperion.com
CONTACT:
Frank Thomas, Vice President, Finance and
Investor Relations of Esperion Therapeutics, +1-734-222-1831, or
Media, Jacqueline Franchetti of JFCI, +1-516-365-2091 for
Esperion Therapeutics
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