Esperion Therapeutics Announces Initiation of Phase 2b Clinical Study of ETC-1002 in Patients With or Without Statin Intolerance and Hypercholesterolemia
Esperion Therapeutics Announces Initiation of Phase 2b Clinical Study of ETC-1002 in Patients With or Without Statin Intolerance and Hypercholesterolemia
October 30, 2013
Represents Company's First Clinical Study in Robust Phase 2b Program
"Dosing of the first patient in our first Phase 2b clinical study is an
important step toward our goal of developing ETC-1002 as an oral
treatment for the two million patients with elevated LDL-C levels who
are unable to tolerate statin therapy," said
The randomized, double-blind, parallel-group, multicenter ETC-1002-008
study is evaluating parallel doses of ETC-1002 as monotherapy or in
combination with ezetimibe in approximately 322 patients. The primary
objective of the study is to assess the LDL-C lowering efficacy of
ETC-1002 monotherapy versus ezetimibe monotherapy in
hypercholesterolemic patients with or without statin intolerance treated
for 12 weeks. Secondary objectives include assessing the effect of
ETC-1002 on additional lipid and cardiometabolic biomarkers;
characterizing the tolerability and safety of ETC-1002; and assessing
the dose range of ETC-1002 to inform Phase 3 dosing. The trial is being
conducted at approximately 75 clinical sites in
In
About Statin Intolerance
According to the USAGE survey, an academic study of approximately 10,000
current and former statin users published in 2012 in the
Therapies most often prescribed for patients with hypercholesterolemia and a history of statin intolerance have reported average LDL-C lowering of up to 18 percent in pivotal clinical studies.
About the ETC-1002 Clinical Development Program
ETC-1002 is a unique, first-in-class, orally available, once-daily small molecule designed to lower levels of LDL-C and to avoid side effects associated with existing LDL-C 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-C levels.
In seven completed Phase 1 and 2 clinical studies, involving more than 300 patients who received ETC-1002, the agent has shown consistent and clinically meaningful reductions in LDL-C cholesterol, as well as reductions comparable to statins 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 and up to 12 weeks in duration.
About
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 and
the study design and anticipated timing for reporting top-line results
from ETC-1002-008. 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
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