Esperion Therapeutics Announces Positive Top-Line Phase 2 Results for ETC-1002 in Patients With Hypercholesterolemia and Hypertension
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Esperion Therapeutics has announced positive top-line results from ETC-1002-014, a Phase II exploratory study evaluating the safety and efficacy of ETC-1002 (bempedoic acid) in patients with both hypercholesterolemia and hypertension.
The 6-week study met its primary endpoint of greater LDL-cholesterol lowering from baseline with ETC-1002 as compared to placebo. Patients treated with 180 mg of ETC-1002 achieved a 21% reduction in LDL-cholesterol 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 2 weeks of initiating therapy and continued throughout the treatment period. The LDL-cholesterol 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).
"This exploratory study is another important milestone in the development of ETC-1002, demonstrating its ability to safely lower LDL-cholesterol in a group of patients with both hypercholesterolemia and hypertension," said Tim M. Mayleben, president and chief executive officer of Esperion. "We are pleased with these results, and with the whole of our phase two program, which continues to demonstrate the potential for ETC-1002 to provide an effective once-daily, oral treatment option for a broad range of patients with hypercholesterolemia."
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