More good news on novel lipid-lowering agent ETC-1002 in patients with hypercholesterolemia
18/03/2015
Phase 2b results show that ETC-1002 (bempedoic acid) safely and effectively lowers LDL-c levels when added to stable statin therapy, as compared with statin therapy alone.
SourceNews - Mar. 18, 2015
The 12-week multicenter, randomized study 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, met its primary endpoint of greater LDL-cholesterol lowering from baseline with ETC-1002.
ETC-1002 is a first-in-class, orally available, once-daily small molecule (bempedoic acid) designed to lower LDL-cholesterol levels. It has a unique dual mechanism of action that has the potential to regulate both lipid and carbohydrate metabolism.
ETC-1002-treated patients achieved 17 (P=0.0055) and 24% (P < 0.0001) incremental reductions in LDL-cholesterol at doses of 120 mg and 180 mg, respectively, compared with patients on stable statin therapy alone (4% LDL-c reduction). These reductions occurred within the first two weeks of initiating therapy, and continued throughout the treatment period.
Consistent with prior studies, ETC-1002 180 mg demonstrated a reduction of 30% (p=0.08) 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 (AEs). There was one reported serious adverse event (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. Muscle-related AEs occurred in 13% of placebo-treated patients, as compared with 5% (120 mg) and 2% (180 mg) of patients receiving ETC-1002.
No clinically meaningful changes in hemoglobin, uric acid, homocysteine, or alkaline phosphatase were observed with ETC-1002.
"ETC-1002 has once again demonstrated impressive incremental LDL-cholesterol lowering. Importantly, ETC-1002 was observed to be safe and well-tolerated when added to stable statin therapy, and may be an appropriate addition to existing therapy in these patients." said Tim M. Mayleben, president and chief executive officer of Esperion.
Press release Esperion 17 March 2015
ETC-1002 is a first-in-class, orally available, once-daily small molecule (bempedoic acid) designed to lower LDL-cholesterol levels. It has a unique dual mechanism of action that has the potential to regulate both lipid and carbohydrate metabolism.
ETC-1002-treated patients achieved 17 (P=0.0055) and 24% (P < 0.0001) incremental reductions in LDL-cholesterol at doses of 120 mg and 180 mg, respectively, compared with patients on stable statin therapy alone (4% LDL-c reduction). These reductions occurred within the first two weeks of initiating therapy, and continued throughout the treatment period.
Consistent with prior studies, ETC-1002 180 mg demonstrated a reduction of 30% (p=0.08) 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 (AEs). There was one reported serious adverse event (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. Muscle-related AEs occurred in 13% of placebo-treated patients, as compared with 5% (120 mg) and 2% (180 mg) of patients receiving ETC-1002.
No clinically meaningful changes in hemoglobin, uric acid, homocysteine, or alkaline phosphatase were observed with ETC-1002.
"ETC-1002 has once again demonstrated impressive incremental LDL-cholesterol lowering. Importantly, ETC-1002 was observed to be safe and well-tolerated when added to stable statin therapy, and may be an appropriate addition to existing therapy in these patients." said Tim M. Mayleben, president and chief executive officer of Esperion.
Press release Esperion 17 March 2015