ANN ARBOR—Esperion Therapeutics Inc. (NASDAQ: ESPR), the Ann Arbor pharma startup developing a new class of cholesterol-fighting drugs, announced positive top-line results from a Phase 2 clinical study of its combination tablet containing its drug candidate bempedoic acid and ezetimibe (study 1002-058).
This was a randomized, double-blind, parallel group study assessing the efficacy and safety of the bempedoic acid-ezetimibe combination tablet compared to ezetimibe and placebo in 179 patients with both high cholesterol and type 2 diabetes. Patients enrolled were on stable background diabetes medications and washed out of lipid modifying therapies.
The 12-week study met its primary endpoints as well as key secondary endpoints, including that the bempedoic acid-ezetimibe combination tablet:
- Significantly lowered LDL-C by 40 percent compared to placebo (p<0.001);
- Reduced high-sensitivity C-reactive protein (hsCRP), an important marker of inflammation associated with cardiovascular disease, by 25 percent (p<0.001);
- No worsening of glycemic control;
- Overall adverse events (AEs) comparable to placebo;
- Had no increase in muscle-related adverse events, serious adverse events, discontinuations due to AEs or elevations in liver function tests;
- Achieved LDL-C levels of less than 70 mg/dl and an LDL-C reduction of more than 50 percent in approximately 40 percent of patients.
The results showed no clinical differences between the bempedoic acid-ezetimibe combination tablet, placebo, and ezetimibe patient groups in the occurrence of:
- Adverse events with 43 percent, 37 percent, and 30 percent, respectively;
- Serious adverse events with 0 percent, 2 percent, and 2 percent, respectively;
- Discontinuations due to adverse events with 0 percent, 0 percent, and 2 percent, respectively;
- No elevations in liver function tests (ALT/AST) (>3X the upper limit of normal, repeated and confirmed) were observed.
“The bempedoic acid-ezetimibe combination tablet provided 40 percent LDL-C lowering, 25 percent hsCRP reductions, and did not worsen glycemic control in patients with both hypercholesteremia and type 2 diabetes on a background of no statin therapy, said Esperion President and CEO Tim Mayleben. “These results build upon the pivotal, Phase 3 bempedoic acid-ezetimibe combination tablet data announced last August, where the majority of patients were on background statin therapy. We have increasing confidence that our convenient, once-daily, oral therapies could become an important, cost-effective treatment option for millions of patients in the U.S. who are not at their LDL-C goal.”
Study 1002-058 was a 12-week, randomized, double-blind, parallel group, multicenter study to evaluate the efficacy and safety of bempedoic acid 180 mg and ezetimibe 10 mg combination tablet compared to ezetimibe 10 mg and placebo in patients with high cholesterol and type 2 diabetes being treated with stable diabetes medication, and who had washed out of lipid modifying therapy due to side effects. The study was conducted at 28 sites in North America. A total of 179 patients were randomized 1:1:1 to receive bempedoic acid 180 mg and ezetimibe 10 mg combination tablet, ezetimibe 10 mg, or placebo.
To listen to a conference call discussing these results, visit investor.esperion.com.
Esperion is developing bempedoic acid to fight high cholesterol, which can lead to cardiovascular disease, in patients who cannot tolerate today’s statin drugs.