ANN ARBOR, Mich.--(BUSINESS WIRE)--
Esperion Therapeutics, Inc. (Nasdaq:ESPR), a clinical-stage
biopharmaceutical company focused on developing and commercializing
first-in-class, oral, low-density lipoprotein cholesterol
(LDL-cholesterol) lowering therapies for the treatment of patients with
hypercholesterolemia and other cardiometabolic risk markers, today
announced dosing of the first patient in its Phase 2 clinical study of
ETC-1002 in patients with hypercholesterolemia and hypertension,
ETC-1002-014. The company expects to announce top-line results from the
study in the second quarter of 2015.
"Many patients with high LDL-cholesterol levels also have hypertension.
This clinical study will help to further elucidate the LDL-cholesterol
lowering efficacy, safety and tolerability profile of ETC-1002 in
patients with both hypercholesterolemia and hypertension," said Tim M.
Mayleben, president and chief executive officer of Esperion.
The randomized, double-blind, parallel group, multicenter ETC-1002-014
study is evaluating parallel doses of ETC-1002 in approximately 144
patients. The primary objective of the study is to assess the
LDL-cholesterol lowering efficacy of ETC-1002 monotherapy versus placebo
in patients with both hypercholesterolemia and hypertension who are
treated for six weeks. Secondary objectives include assessing the effect
of ETC-1002 on blood pressure, other lipid and cardiometabolic
biomarkers and characterizing the tolerability and safety of ETC-1002.
About the ETC-1002 Clinical Development Program
ETC-1002 is a novel, first-in-class, orally available, once-daily small
molecule designed to lower levels of LDL-cholesterol and to avoid side
effects associated with existing LDL-cholesterol lowering therapies.
ETC-1002 has a unique dual
mechanism of action that has the potential to regulate both lipid
and carbohydrate metabolism. ETC-1002 works by inhibiting ATP citrate
lyase (ACL), a key enzyme in the cholesterol biosynthetic pathway, and
activating a complementary enzyme, 5′-adenosine monophosphate-activated
protein kinase (AMPK). Both enzymes are known to play significant roles
in the synthesis of cholesterol and glucose in the liver. By inhibiting
cholesterol synthesis in the liver, ETC-1002 causes the liver to take up
LDL particles from the blood, which reduces LDL-cholesterol levels.
In seven completed Phase 1 and 2 clinical studies in more than 300
patients, ETC-1002 has shown consistent and clinically meaningful
reductions in LDL-cholesterol, as well as reductions in levels of high
sensitivity C-reactive protein (hsCRP), a key marker of inflammation
associated with cardiovascular disease. Across all completed clinical
studies, ETC-1002 has been well tolerated. To date, one serious adverse
event, considered unrelated to ETC-1002, has been observed in 317
patients treated with ETC-1002 at doses of up to 240 mg for up to 12
weeks in duration.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a clinical stage biopharmaceutical
company focused on developing and commercializing first-in-class, oral,
LDL-cholesterol lowering therapies for the treatment of patients with
hypercholesterolemia and other cardiometabolic risk markers. ETC-1002,
Esperion's lead product candidate, is a unique, first-in-class, orally
available, once-daily small molecule designed to lower LDL-cholesterol
levels and avoid the side effects associated with therapies currently
available for lowering LDL-cholesterol. ETC-1002 is being developed
initially for the treatment of patients with hypercholesterolemia and a
history of statin intolerance. Phase 2b clinical trials for ETC-1002 are
currently underway and build upon the successful and comprehensive Phase
1 and Phase 2a programs. For more information, please visit www.esperion.com
and follow us on Twitter at https://twitter.com/EsperionInc.
Esperion's Commitment to Cardiometabolic Disease
Esperion is committed to improving the lives of patients with
cardiometabolic diseases. The Esperion team leverages its understanding
of and experience with key biological pathways to discover or license
and develop innovative therapies for the treatment of patients with
unmet needs, especially those patients with hypercholesterolemia who
have uncontrolled cholesterol levels despite the use of currently
available therapies. Esperion has assembled a portfolio of programs
including one product candidate in late-stage clinical development
(ETC-1002) and two additional pre-clinical product candidates.
Forward Looking Statements
This press release contains forward-looking statements that are made
pursuant to the safe harbor provisions of the federal securities laws,
including statements regarding the therapeutic potential of ETC-1002,
the study design and anticipated timing for reporting top-line results
from ETC-1002-014 and the status and potential of Esperion's
pre-clinical product candidates. Any statements contained in this press
release that are not statements of historical fact may be deemed to be
forward-looking statements. Forward-looking statements involve risks and
uncertainties that could cause Esperion's actual results to differ
significantly from those projected, including, without limitation, the
risk that unanticipated developments could interfere with the
development (and commercialization) of ETC-1002, as well as other risks
detailed in Esperion's filings with the Securities and Exchange
Commission, including our Annual Report on Form 10-K filed with the
Securities and Exchange Commission on March 13, 2014. You are cautioned
not to place undue reliance on the forward-looking statements, which
speak only as of the date of this release. Esperion disclaims any
obligation or undertaking to update or revise any forward-looking
statements contained in this press release, other than to the extent
required by law.
Source: Esperion Therapeutics, Inc.