ANN ARBOR — Esperion Therapeutics Inc. announced positive top-line results from the third of five pivotal Phase 3 studies expected to be reported this year to evaluate the efficacy in lowering so-called bad cholesterol.
The tests were done on Esperion’s, lead drug candidate, bempedoic acid, at a dose of 180 milligrams, vs. placebo in high-risk patients with atherosclerotic cardiovascular disease, or at high risk with high cholesterol, who were considered intolerant to today’s statin drugs. The results are consistent with the previously reported results in patients considered statin intolerant.
The 24-week study achieved LDL-C lowering totaling 26 percent in patients on bempedoic acid who remained on treatment at both week 12 and week 24, compared with placebo which had a decrease of 2 percent. Patients treated with bempedoic acid also achieved a significantly greater reduction of 25 percent in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, compared with placebo which had an increase of 3 percent.
Muscle-related adverse events were lower in the bempedoic acid group than in the placebo group. There were no clinically relevant differences in the occurrence of adverse events and no differences between the treatment group and the placebo group in discontinuations due to muscle-related AEs which are commonly associated with statin intolerance.
“The dataset from this study is reassuring and highly consistent with what we’ve seen previously with bempedoic acid. For the millions of patients with hypercholesterolemia who are considered statin intolerant and have limited treatment options, bempedoic acid provides meaningful LDL-cholesterol lowering and statin-like reductions in hsCRP,” said Professor Dr. med Ulrich Laufs, member of Esperion’s Phase 3 Executive Committee and Director of the Department of Cardiology at Leipzig University. “The medical community is in need of a new oral therapy which is effective, well tolerated and convenient for this complex patient population who may have run out of other options.”
The company said the cumulative Phase 2 and Phase 3 results from more than 4,000 total patients have demonstrated broad efficacy as well as safety and tolerability for bempedoic acid in high-risk patients for arterial disease who are inadequately treated with maximally tolerated background LDL-C lowering therapy or are considered statin intolerant. Bempedoic acid has provided LDL-C lowering of an additional 20 to 24 percent for those on background statin therapy, and 23 to 30 percent for patients not taking statins. Patients treated with bempedoic acid have also achieved a reduction of 22 to 40 percent in hsCRP.
“These results add to the already substantial body of evidence that bempedoic acid can be an important new complementary and convenient, once-daily oral treatment option for patients with ASCVD, or at a high risk for ASCVD, in need of additional LDL-cholesterol lowering, especially those considered statin intolerant,” said Tim M. Mayleben, president and CEO of Esperion. “We eagerly anticipate the pivotal Phase 3 study results for our lead product candidate, the bempedoic acid / ezetimibe combination pill, in late August, and the fourth and final pivotal Phase 3 study of bempedoic acid, Study 2, in late September. Both studies include ASCVD patients on maximally tolerated statin therapy. The medical community is awaiting new, once-daily oral therapies that complement existing oral drugs to provide the LDL-C lowering and hsCRP reductions that their high-risk patients need, the value that payers appreciate, and the convenience and tolerability that patients want and deserve.”
Esperion plans to present full results from this study at an upcoming medical conference and to publish in a major medical journal.
The 24-week study was conducted at 67 sites in the United States and Canada and involved 345 patients.
To listen to a replay of a conference call discussing the study’s results, visit www.esperion.com.
Esperion plans to submit New Drug Applications to the U.S. Food and Drug Administration for bempedoic acid and the bempedoic acid / ezetimibe combination pill for LDL-C-lowering indications no later than the first quarter of 2019. Additionally, Esperion plans to submit Marketing Authorization Applications to the European Medicines Agency no later than the second quarter of 2019.