17.03.2015 12:38:27
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Esperion Therapeutics Announces Positive Phase 2b Results For ETC-1002
(RTTNews) - Esperion Therapeutics Inc. (ESPR) announced positive top-line results from ETC-1002-009, a Phase 2b study evaluating the efficacy and safety of ETC-1002 (bempedoic acid) compared with placebo in patients with hypercholesterolemia on stable statin therapy.
Top-line results showed the 12-week study met its primary endpoint of greater LDL-cholesterol lowering from baseline with ETC-1002 compared with placebo. ETC-1002-treated patients achieved 17 and 24 percent incremental reductions in LDL-cholesterol at doses of 120 mg and 180 mg, respectively, compared with patients on stable statin therapy alone.
These reductions were significantly different from placebo (p=.0055 and p<.0001, respectively), occurred within the first two weeks of initiating therapy, and continued throughout the treatment period.
Consistent with prior studies, ETC-1002 demonstrated reductions of up to 30 percent in high-sensitivity C-reactive protein (hsCRP), an important marker of inflammation in coronary disease.
ETC-1002 produced no increases in muscle-related adverse events or AEs. There was one reported serious adverse event or SAE in the ETC-1002 treatment arms, which was not drug-related. Discontinuation rates were low overall and lower in ETC-1002-treated patients than those seen in placebo, and were not muscle-related.
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