ANN ARBOR, Mich., Sept. 18 /PRNewswire-FirstCall/ --
Esperion Therapeutics, Inc. (Nasdaq: ESPR), a biopharmaceutical company
focused on discovering and developing HDL-targeted therapies, today announced
the initiation of a second Phase I clinical study of its RLT Peptide product
candidate (ETC-642) in patients with existing vascular disease. This study is
designed to evaluate the safety and tolerability of ETC-642 at higher dose
levels than those evaluated in the first clinical study.
This trial is a randomized, double-blind, placebo-controlled, dose-
escalating study of up to twenty patients with stable atherosclerosis. In
addition to safety and tolerability, the study will evaluate the
pharmacokinetics and lipid effects of three dose levels of a single
intravenous infusion of ETC-642. This trial will be conducted at Mayo Clinic.
Mehmood A. Khan, MD, an endocrinologist and Director, Diabetes, Endocrine and
Nutrition Clinical Trials Unit at the Mayo Clinic, will serve as the principal
investigator of the study.
"We are pleased that the positive safety profile in the first clinical
trial of ETC-642 has given us the opportunity to evaluate higher doses of ETC-
642 in this study," stated Roger S. Newton, Ph.D., President and CEO of
Esperion. "With the data from this second study, we can design the protocol
for a multiple dose study in patients for ETC-642."
ETC-642 mimics the biological properties of apolipoprotein A-I, the major
protein in HDL, to promote cholesterol removal from arterial walls and other
tissues and enhance reverse lipid transport. ETC-642 is a complex of peptide
and phospholipids that mimics the functions of natural HDL and is being
developed for the treatment of acute coronary disease. ETC-642 has been shown
to increase HDL-cholesterol levels and to enhance cholesterol mobilization in
preclinical studies and the first Phase I clinical study. Because of these
properties, Esperion believes that the administration of ETC-642 may stimulate
cholesterol removal in patients.
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 Investor Relations (516) 365-2091
(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, Inc.,
+1-734-222-1831; or Media: Jacqueline Franchetti of JFCI,
+1-516-365-2091, for Esperion Therapeutics, Inc.
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