ANN ARBOR — Esperion Therapeutics Inc. (Nasdaq:ESPR), Monday announced the start of a Phase 3 study to assess the safety and efficacy of a combination pill containing its cholesterol-fighter, bempedoic acid, with ezetimibe, a drug that decreases cholesterol absorption in the small intestine.
Ezetimibe is used when other cholesterol-lowering medications, such as statins, are not tolerated well by the patient.
Those in the study are patients with high cholesterol and cardiovascular disease, whose cholesterol is not adequately controlled by existing therapies.
The company said initial results are expected by the end of 2018.
“Initiating the pivotal Phase 3 study for the bempedoic acid-ezetimibe combination pill puts us on track to report results from all five pivotal Phase 3 studies for the bempedoic acid franchise in 2018,” said Tim M. Mayleben, Esperion president and CEO. “The bempedoic acid-ezetimibe combination pill and bempedoic acid are the only convenient, complementary, cost-effective, once-daily, oral therapies in late-stage development for the millions of high-risk patients with hypercholesterolemia who are inadequately treated with, or unable to gain access to, current lipid-modifying therapies.”
The 12-week, pivotal Phase 3, randomized, double-blind, placebo-controlled, parallel-dose study will consist of four treatment arms evaluating the efficacy and safety of a once-daily, oral, fixed dose combination pill of 180 mg of bempedoic acid and 10 mg of ezetimibe versus placebo, 180 mg of bempedoic acid alone and 10 mg of ezetimibe alone.
The study is expected to enroll approximately 350 patients at up to 125 U.S. sites.
The primary objectives of the study are to assess LDL-C lowering efficacy in patients treated with the bempedoic acid-ezetimibe combination pill versus placebo, 180 mg of bempedoic acid and 10 mg of ezetimibe alone.
Secondary objectives include assessing the safety and tolerability of the bempedoic acid-ezetimibe combination pill versus placebo, 180 mg of bempedoic acid and 10 mg of ezetimibe alone and effects on other risk markers, including high sensitivity C-reactive protein (hsCRP), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apoB) and total cholesterol.
Through the complementary mechanisms of action of inhibition of cholesterol synthesis (bempedoic acid) and inhibition of cholesterol absorption (ezetimibe), the bempedoic acid-ezetimibe combination pill is Esperion’s lead, non-statin, orally available, once-daily, LDL-C lowering therapy.
Previously completed Phase 2 data demonstrated that this safe and well tolerated combination results in a 48 percent lowering of LDL-C, a 26 percent reduction in high sensitivity C-reactive protein (hsCRP), and may potentially be associated with a lower occurrence of muscle-related side effects.
Esperion officials said that In the United States, 78 million people, or more than 20 percent of the population, have elevated LDL-C; an additional 73 million people in Europe and 30 million people in Japan also live with elevated LDL-C. It is estimated that 40 million patients in the U.S. are taking statins, with 5 to 20 percent of these patients only able to tolerate less than the lowest approved daily starting dose of their statin and are therefore considered to be statin intolerant.
More at www.esperion.com.