Esperion Reveals Positive Top-line Phase 2b Results For ETC-1002 - Quick Facts

(RTTNews) - Esperion Therapeutics Inc (ESPR), Wednesday announced positive top-line results from ETC-1002-008, a Phase 2b study evaluating the efficacy and safety of ETC-1002 monotherapy compared with ezetimibe monotherapy in patients with hypercholesterolemia, with or without statin intolerance.

Top-line results showed the 12-week study met its primary endpoint of greater LDL-cholesterol lowering from baseline with ETC-1002 compared with ezetimibe.

In patients who received ETC-1002 as monotherapy, there were 27 and 30 percent reductions in LDL-cholesterol at doses of 120 mg and 180 mg, respectively. These reductions were significantly different from ezetimibe alone.

In patients who received the combination of 120 mg of ETC-1002 and 10 mg ezetimibe, substantial LDL-cholesterol reductions of 43 percent were significantly different from ezetimibe alone.

In patients who received the combination of 180 mg of ETC-1002 and 10 mg ezetimibe, substantial LDL-cholesterol reductions of 48 percent were significantly different from ezetimibe.

These reductions occurred within the first two weeks of dosing and continued throughout the treatment period.

ETC-1002 monotherapy and ETC-1002 in combination with ezetimibe demonstrated significantly greater reductions than ezetimibe in high-sensitivity C-reactive protein (hsCRP), an important marker of inflammation in coronary disease.

ETC-1002 appeared to be safe and well-tolerated. Discontinuation rates due to adverse events (AEs) with ETC-1002 were comparable to those seen with ezetimibe.