ANN ARBOR, Mich., Dec. 16 /PRNewswire-FirstCall/ -- 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 randomized, 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 mobilization
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 mobilization, 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
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 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 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 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 Amy Cannon
Contact: Manager, Corporate Communications
Esperion Therapeutics, Inc.
(734) 222-1801
acannon@esperion.com
Media Bill Berry
Contact: Berry & Company Public Relations
(212) 253-8881
bberry@berrypr.com
SOURCE Esperion Therapeutics, Inc.
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Related links:
http://www.esperion.com
CONTACT:
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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