Esperion Reports Positive Results for Second Phase 1 Study of ETC-642
December 16 2003 - 8:00AM
PR Newswire (US)
Esperion Reports Positive Results for Second Phase 1 Study of
ETC-642 ANN ARBOR, Michigan, December 16 /PRNewswire/ -- Esperion
Therapeutics, Inc. (Nasdaq: ESPR) today announced the completion of
a second Phase 1 study of the Company's ETC-642 (RLT Peptide)
investigational product candidate. Results of clinical studies
completed to date provide evidence that the investigational therapy
was safe and well tolerated at dose levels intended for future
clinical development. The Phase 1 randomised, double-blind,
placebo-controlled study of 20 patients with stable cardiovascular
disease was designed to determine the maximum tolerated dose for
single intravenous infusions of ETC-642. In an earlier Phase 1
clinical trial, there was evidence of cholesterol mobilisation at
dose levels of 3 mg/kg and higher of ETC-642. In this second trial,
patients received one of three dose levels (10, 20 or 30 mg/kg) of
ETC-642 or placebo and were monitored for 30 days following dosing.
Results of the study, together with results of the first clinical
trial, provided evidence of safety and tolerability for single
infusions of ETC-642 at the dose levels tested. At 30 mg/kg, the
highest dose level tested, investigators observed evidence of
asymptomatic elevations of liver function tests in a single
patient, suggesting that a maximum tolerated dose had been
identified. The results from this study were consistent with
pre-clinical studies in demonstrating evidence of rapid
dose-related cholesterol mobilisation, as well as evidence of
increases in HDL-cholesterol levels. John M. Miles, M.D., Professor
of Medicine at the Mayo Clinic College of Medicine and Consultant
in Endocrinology and Metabolism at the Mayo Clinic in Rochester,
Minnesota, served as the study's principal investigator. ETC-642, a
complex of a 22-amino acid peptide and phospholipids, is being
developed for the treatment of patients with acute coronary
syndromes (ACS). ETC-642 was designed to mimic HDL, the "good"
cholesterol, to promote the removal of excess cholesterol and other
lipids from artery walls and other tissues and enhance reverse
lipid transport. Esperion is working to demonstrate that the
peptide component of ETC-642 mimics the biological properties of
apolipoproteinA-I (ApoA-I), the major protein in HDL. In June 2003,
Esperion initiated a multiple-dose Phase 1 clinical trial of
ETC-642 in patients with stable cardiovascular disease to assess
potential dose levels and evaluate safety and tolerability. ETC-642
is one of four product candidates in clinical development at
Esperion. In November, Esperion announced positive results from a
Phase 2 study of ETC-216 (AIM), a product candidate being developed
for the treatment of ACS patients. ETC-216 is a human recombinant
version of ApoA-I Milano, a variant form of ApoA-I, combined with a
phospholipid to form a complex that mimics HDL. Esperion
Therapeutics Esperion Therapeutics, Inc. discovers and develops
pharmaceutical products for the treatment of cardiovascular
disease. Esperion intends to commercialise 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 artery walls 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 four product candidates in clinical development.
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,"
"require," "intend," "assume" and similar expressions.
Forward-looking statements speak only as of the date of this press
release, reflect management's current expectations, estimations and
projections and involve certain factors, such as risks and
uncertainties, that may cause actual results, performance or
achievements 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: the Company's ability to
successfully execute its business strategies, including entering
into 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; the Company's 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;
litigation, proceedings, investigations and other disruptions of
management's time resulting from the acquisition of the Company's
common stock by various persons associated with Scott Sacane; the
procurement, maintenance, enforcement and defence 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 future products may be sold; extraordinary events and
transactions; seeking and consummating business acquisitions,
including the diversion of management's attention to the
assimilation of the operations and personnel of any acquired
business; the timing and extent of the Company's financing needs
and the Company's access to funding, including through the equity
market, particularly in light of the impact on the market value of
the Company's common stock of matters outside of the Company's
control, such as trading activities by third parties; fluctuations
in foreign exchange rates; and economic conditions generally or in
various geographic areas. Because all of the foregoing factors are
difficult to forecast, you should not place undue reliance on any
forward-looking statement. More detailed information about some of
these and other risk factors is set forth 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
contact: Amy Cannon Manager, Corporate Communications Esperion
Therapeutics, Inc. +1-734-222-1801 acannon@esperion.com Media
contact: Bill Berry Berry & Company Public Relations
+1-212-253-8881 bberry@berrypr.com Web site:
http://www.esperion.com DATASOURCE: Esperion Therapeutics, Inc.,
company contact: Amy Cannon, Manager, Corporate Communications of
Esperion Therapeutics, Inc., +1-734-222-1801, acannon@esperion.com;
media contact: Bill Berry of Berry & Company Public Relations,
+1-212-253-8881, bberry@berrypr.com
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