Esperion Announces Positive Results of Phase 1 Study of ETC-1001
December 04 2003 - 8:00AM
PR Newswire (US)
Esperion Announces Positive Results of Phase 1 Study of ETC-1001
ANN ARBOR, Michigan, December 4 /PRNewswire/ -- Orally-administered
small molecule product candidate is in development as a chronic
treatment for lipid disorders Esperion Therapeutics, Inc. (Nasdaq:
ESPR) today announced the successful completion of a Phase 1 study
of ETC-1001, the Company's first small molecule investigational
product candidate. Results of the study provide evidence that the
investigational therapy was safe and well tolerated in healthy
volunteers receiving a single dose of ETC-1001. Esperion expects to
initiate a multiple-dose Phase 1 study of ETC-1001 in the first
half of 2004. The Phase 1 clinical trial was a double-blind,
placebo-controlled study of 36 healthy volunteers and was designed
to determine the safety and tolerability of escalating doses of
ETC-1001. Volunteers received single doses of ETC-1001 over a broad
range of dose levels and were monitored for 72 hours following
dosing. The results indicate that ETC-1001 was safe and well
tolerated at all dose levels tested. No serious adverse events
occurred. Esperion's small molecule discovery program is focused on
identifying and developing new treatments for patients with lipid
disorders, which can be characterised by excess levels of
LDL-cholesterol, the "bad" cholesterol, and triglycerides and/or
low levels of HDL-cholesterol, the "good" cholesterol. According to
the American Heart Association, patients with lipid disorders are
at elevated risk for developing heart disease. Esperion intends to
develop small molecules as orally-administered chronic therapies to
complement existing medications such as statins. In addition to
ETC-1001, other small molecules in pre-clinical development at
Esperion show promise as potential candidates for future clinical
development. Esperion was recently granted a fourth patent for the
small molecule discovery program. Eleven additional U.S. patent
applications and corresponding foreign applications are pending in
support of the small molecule program. "We continue to see great
potential in the application of oral small molecule therapies for
the treatment of lipid disorders and are encouraged by the results
of our efforts thus far," stated Roger S. Newton, Ph.D., President
and CEO of Esperion Therapeutics. "With the positive results from
the Phase 1 study of ETC-1001, our progress in pre-clinical
research and our strong and growing patent estate, Esperion is well
positioned to develop the small molecule discovery program."
ETC-1001 is a synthetic, orally-active, lipid-regulating agent
designed to elevate levels of HDL-cholesterol. In pre-clinical
studies, ETC-1001 demonstrated the ability to elevate
HDL-cholesterol levels, while also reducing levels of
LDL-cholesterol and triglycerides. ETC-1001 was also shown to
inhibit the progression of atherosclerosis in pre-clinical studies.
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 for transport 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
Amy Cannon Contact: Manager, Corporate Communications Esperion
Therapeutics, Inc. +1 (734) 222-1801 acannon@esperion.com Media Jim
Wetmore Contact: Berry & Company Public Relations +1 (212)
253-8881 jwetmore@berrypr.com DATASOURCE: PR Newswire (New York)
CONTACT: Amy Cannon, Manager, Corporate Communications of Esperion
Therapeutics, Inc., +1-734-222-1801, acannon@esperion.com ; or Jim
Wetmore of Berry & Company Public Relations, +1-212-253-8881,
jwetmore@berrypr.com , for Esperion Therapeutics, Inc. FCMN
Contact: jwetmore@berrypr.com Web site: http://www.esperion.com
(ESPR)
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