ANN ARBOR — Esperion Therapeutics Inc. (NASDAQ:ESPR), the Ann Arbor-based pharmaceutical startup, announced the initiation of a Phase 2 clinical study (1002-039) to assess the efficacy and safety of its drug candidate, bempedoic acid, in addition to another form of injectable cholesterol-fighter.
The study will assess the incremental LDL-C lowering efficacy and continued safety and tolerability of a once-daily, oral bempedoic acid pill added to a therapy called injectable proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i).
Initial results are expected by March, 2018.
The eight-week, Phase 2, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of once-daily, oral bempedoic acid 180 mg and once-monthly injection of Repatha (evolocumab) 420 mg versus placebo. The study is expected to enroll approximately 50 patients with high cholesterol at about 20 sites across the United States.
The primary objective of the study is to assess the incremental lowering efficacy of so-called “bad cholesterol” by bempedoic acid versus placebo in patients receiving PCSK9i therapy. Secondary objectives include assessing the safety and tolerability of bempedoic acid versus placebo in patients on PCSK9i therapy and effects on other risk markers, including non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, apolipoprotein B (apoB) and high sensitivity C-reactive protein (hsCRP).
“From our recent market research it’s clear there remains a strong preference among patients, physicians and payers for convenient, cost-effective, once-daily, oral LDL-C lowering therapies that can be used with currently available therapies,” said Tim M. Mayleben, president and CEO of Esperion. “It is important to note that we don’t intend to explore bempedoic acid added-on to a PCSK9i in further studies due to their limited use to date. In this Phase 2 study, we anticipate that we will see the favorable safety, tolerability and incremental LDL-C lowering efficacy that we have come to expect from bempedoic acid.”
Completed Phase 1 and 2 studies conducted in more than 1,000 patients and over 800 patients treated with bempedoic acid have produced clinically relevant LDL-C lowering results of up to 30 percent as monotherapy and an incremental 20+ percent when added to stable statin therapy.
Esperion estimates that 78 million people, or more than 20 percent of the U.S. population, have elevated LDL-C; an additional 73 million people in Europe and 30 million people in Japan also live with elevated LDL-C, a risk factor for heart disease.
It is estimated that 40 million patients in the U.S. are taking statins with approximately 5 to 20 percent of these patients only able to tolerate less than the lowest approved daily starting dose of their statin due to side effects such as muscle pain and weakness.
Esperion-discovered and developed, bempedoic acid is a targeted LDL-C lowering therapy in Phase 3 development.
More at http://www.esperion.com.