Orally-administered small molecule product candidate is in development
as a chronic treatment for lipid disorders
ANN ARBOR, Mich., Dec. 4 /PRNewswire-FirstCall/ -- 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
characterized 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
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 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 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 Jim Wetmore
Contact: Berry & Company Public Relations
(212) 253-8881
jwetmore@berrypr.com
SOURCE Esperion Therapeutics, Inc.
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Related links:
http://www.esperion.com
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.
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