Esperion Therapeutics Announces Positive Top-Line Results from Phase 2 Clinical Study of ETC-1002 as an Add-On to Statin Therapy in Patients with Hypercholesterolemia
Esperion Therapeutics Announces Positive Top-Line Results from Phase 2 Clinical Study of ETC-1002 as an Add-On to Statin Therapy in Patients with Hypercholesterolemia
September 3, 2013
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"Since a 10 mg dose of atorvastatin provides 30 to 35 percent LDL-C
lowering, the addition of ETC-1002 could potentially provide LDL-C
lowering of greater than 55 percent with an oral dosing regimen. While
statin therapy remains the standard of care for high cholesterol, it is
estimated that 11 million Americans are still unable to reach their
LDL-C treatment goals despite taking a statin," said
"This study answered important questions about the safety, tolerability and efficacy of ETC-1002 as an add-on to statin therapy," said Tim M. Mayleben, president and chief executive officer of Esperion. "We are now in a position to build on these positive results with a robust, parallel-dose design Phase 2b study to establish further the potential of ETC-1002 to provide incremental LDL-C lowering for patients already taking a statin and not at their LDL-C goal."
ETC-1002-007 Design
The ETC-1002-007 study was a randomized, double-blind, placebo-controlled, multicenter, Phase 2a study to evaluate the safety and tolerability of ETC-1002 when added to 10 mg of atorvastatin and assess the effect of ETC-1002 on the pharmacokinetics of atorvastatin in patients with hypercholesterolemia. Secondary objectives were to assess the effect of ETC-1002 on LDL-C and other cardiometabolic risk factors when added to atorvastatin. Fifty-eight patients with hypercholesterolemia were washed out of any lipid regulating therapies prior to a four week run-in period on 10 mg atorvastatin (mean baseline LDL-C levels of 106 mg/dL at week 0 prior to randomization). Forty-two of these patients were randomized to receive ETC-1002 plus 10 mg atorvastatin. All ETC-1002 treated patients received escalating daily doses of 60, 120, 180 and 240 mg ETC-1002, each over a two week period, for a total of eight weeks. Sixteen patients received placebo plus 10 mg atorvastatin also for eight weeks.
ETC-1002-007 Results
Adverse events (AEs) were generally mild and no SAEs were observed in either the ETC-1002 or placebo groups. Thirty-nine out of 42 ETC-1002 treated patients (93%) and 14 out of 16 placebo treated patients (88%) completed eight weeks of treatment. Two patients in the ETC-1002 plus atorvastatin group withdrew from the study due to AEs. One patient had an elevated liver enzyme laboratory finding that resolved when ETC-1002 and atorvastatin were discontinued. The other patient's AE was unrelated to ETC-1002. There was a weak pharmacokinetic interaction of ETC-1002 with atorvastatin. ETC-1002 treated patients achieved incremental LDL-C lowering of 22 percent at eight weeks, compared with 0 percent in the placebo group, when added to 10 mg of atorvastatin (p < 0.0001).
Limitations of Statin Therapy
Statins are the standard of care for LDL-C lowering treatment today and
are highly effective at lowering LDL-C. The benefits of using statins to
lower LDL-C levels and improve cardiovascular outcomes are well
documented. However, a significant number of patients are unable to
tolerate statins due to the side effects, primarily muscle pain or
weakness. Based on data from the USAGE survey, as published in the
Conference Call Details
The Esperion management team will host a conference call and webcast
today at
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,
Esperion's plans to submit the full results of ETC-1002-007 for
publication or presentation and the study design of Esperion's Phase 2b
ETC-1002-009 clinical study. 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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