Esperion announces initial study results showing use of
HDL mimetic decreases percent plaque volume in coronary arteries.
ANN ARBOR, Mich., June 26 /PRNewswire-FirstCall/ --
Esperion Therapeutics, Inc. (Nasdaq: ESPR), a biopharmaceutical company
focused on discovering and developing high-density lipoprotein (HDL) -targeted
therapies for the treatment of cardiovascular disease, today announced initial
results from a multiple-dose, multi-center Phase II clinical study of its
investigational product ETC-216 (AIM or ApoA-I Milano/phospholipid complex) in
patients with acute coronary syndromes (ACS). The study met its primary
efficacy objective of demonstrating statistically significant regression of
atherosclerosis with ETC-216.
The purpose of this clinical trial was to investigate whether ETC-216 was
effective in regressing coronary atherosclerosis. Changes in plaque size were
measured using intravascular ultrasound (IVUS). In IVUS, a tiny ultrasound
probe is inserted into the coronary artery to directly image atherosclerotic
plaques. The trial was a randomized, double-blind study evaluating the
efficacy of ETC-216 at two different levels of intravenous infusions (15 mg/kg
and 45 mg/kg), compared to placebo, administered every seventh day for a
maximum of five doses. The study evaluated forty-seven patients with ACS, who
were scheduled to undergo coronary angiography. The primary endpoint was the
change in percent atheroma (plaque) volume for the evaluable patients in the
combined ETC-216 treatment arms comparing end-of-treatment values to baseline
values as measured with IVUS.
The trial was conducted in conjunction with the Cleveland Clinic
Foundation, one of the largest and most respected cardiovascular centers in
the United States. Steven E. Nissen, M.D., F.A.C.C., Medical Director of the
Cleveland Clinic Cardiovascular Coordinating Center, served as the study's
principal investigator. Other centers participating in the study included
Integris Southwest Hospital in Oklahoma City, Oklahoma; Borgess Medical Center
in Kalamazoo, Michigan; Mid Ohio Heart Clinic in Mansfield, Ohio; North Ohio
Heart Center in Elyria, Ohio; William Beaumont Hospital in Royal Oak,
Michigan; Medical College of Ohio in Toledo, Ohio; and Radiant Research in
Santa Rosa, California.
Further details regarding the results of this trial will be available at
the time of presentation of the complete study results (pending additional
efficacy parameters as well as safety and tolerability analyses) at an
appropriate scientific meeting and/or publication in a peer reviewed journal.
ApoA-I Milano is a variant of ApolipoproteinA-I (ApoA-I), the major
protein component of HDL. HDL is believed to effectively protect against
cardiovascular disease by efficiently removing cholesterol and other lipids
from artery walls and other tissues and transporting them to the liver for
elimination. The mechanism of AIM as a human recombinant protein complexed to
phospholipid is to mimic HDL and its function in a process called reverse
lipid transport (RLT). ApoA-I Milano is present in a small population of
northern Italians with paradoxically low levels of HDL-cholesterol. Low HDL-
cholesterol levels normally would correlate with high risk for cardiovascular
disease, but carriers of the ApoA-I Milano gene show a reduced risk,
presumably due to enhanced RLT.
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
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 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 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; 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 laws.
Company Contact: Frank Thomas
VP, Finance and Investor Relations
Esperion Therapeutics, Inc.
(734) 222-1831
fthomas@esperion.com
Media Contact: Jim Wetmore
Berry & Company Public Relations
(212) 253-8881
jwetmore@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: Jim
Wetmore of Berry & Company Public Relations, +1-212-253-8881,
jwetmore@berrypr.com
|
