New lipid-lowering agent meets primary endpoint in hypercholesterolaemic patients with co-morbid hypertension
Top-Line phase 2 results for ETC-1002 in patients with hypercholesterolaemia and hypertension
Positive top-line results were obtained with ETC-1002 (bempedoic acid) in a Phase 2 exploratory study in patients with both hypercholesterolaemia and hypertension. A total of 143 patients were washed out of any lipid-regulating and blood pressure therapies. Seventy one patients received ETC-1002 180 mg and 72 patients received placebo.
The six-week multi-centre, randomized, double-blind, placebo-controlled, parallel group study evaluating the safety and efficacy of ETC-1002 met its primary endpoint of greater LDL-c lowering from baseline with ETC-1002 as compared to placebo. Patients treated with 180 mg of ETC-1002 achieved a 21% reduction in LDL-c from baseline (P < 0.0001), and a 24% reduction as compared to placebo (P < 0.0001), which increased by 3%. The reduction occurred within the first two weeks of initiating therapy and continued throughout the treatment period. The LDL-c lowering effect of ETC-1002 was statistically significant and clinically meaningful.
Consistent with prior studies, ETC-1002 demonstrated statistically significant and clinically meaningful reductions of 25% from baseline, 44% vs placebo P < 0.0001), in high-sensitivity C-reactive protein (hsCRP), an important marker of inflammation in coronary disease.
ETC-1002 produced a neutral effect on blood pressure, appeared to be safe and well-tolerated and produced no muscle-related adverse events (AEs) or liver function test elevations. There were four reported serious adverse event (SAEs) in the ETC-1002 treatment arm, none of which were drug-related, with two discontinuations.
ETC-1002 has demonstrated consistent LDL-c reduction throughout its phase 2 development programme, including in comparison with patients treated with stable statin therapy alone, or with ezetimibe alone. The combination of ETC-1002 and ezetimibe yielded even larger LDL-c reductions.
Press release Esperion Therapeutics July 28 2015