Blog Exposure - Esperion Therapeutics Reported Positive Top-line Results from First Pivotal Phase-3 Study of its Cholestrol Drug, Bempedoic Acid
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LONDON, UK / ACCESSWIRE / March 09, 2018 / Active-Investors.com has just released a free research report on Esperion Therapeutics, Inc. (NASDAQ: ESPR) ("Esperion"). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ESPR as the Company's latest news hit the wire. On March 07, 2018, the Company announced positive top-line results from the first pivotal, Phase-3 trial (Study 4/1002-048) evaluating the low-density lipoprotein cholesterol (LDL-C) lowering efficacy and tolerability of bempedoic acid in patients with atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD with hypercholesterolemia, despite treatment with ezetimibe or lowest starting dose of a statin. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Esperion Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
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Study 4 (1002-048) Met its Primary Endpoint
The Study 4, a global, pivotal, Phase-3 randomized, double-blind, placebo-controlled, multicenter trial enrolled 269 patients from 90 sites in the US, Canada, and Europe. Patients received a daily 180 mg dose of bempedoic acid. After 12-weeks, the study met its primary endpoint with LDL-C reduction of 28%. The LDL-C was reduced by 23% in the bempedoic acid and increased by 5% in the placebo group. Patients treated with bempedoic acid also achieved a significantly greater reduction of 33% in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease compared to the placebo group which had an increase of 2%.
Bempedoic acid was observed to be safe and well-tolerated. There were no differences in the occurrence of adverse events in the bempedoic acid group compared to the placebo group. Two patients treated with bempedoic acid had elevations in liver function tests (ALT/AST) of greater than three times the upper limit of normal, repeated and confirmed.
Esperion is Expected to Report Results from Four Additional Pivotal Studies in 2018
The Company is likely to report results from four additional pivotal studies in 2018, including two studies in 3,000 patients with ASCVD taking maximally-tolerated statins whose results are expected in early May and September 2018, respectively. The other two studies in 600 statin-intolerant patients with ASCVD, with results expected in May 2018 and early March 2018, respectively. Esperion will also report results of one study combining bempedoic acid and ezetimibe in 350 patients taking maximally-tolerated statins in August 2018.
Esperion to Submit NDAs to FDA in Q1 2019
Esperion plans to submit New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for bempedoic acid and the bempedoic acid/ ezetimibe combination pill for LDL-C-lowering indications in Q1 2019. Additionally, Esperion plans to submit Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) in Q2 2019.
As per the news reports post announcement of the news, Esperion's shares were up by 4% in premarket trading.
About Atherosclerotic Cardiovascular Disease
ASCVD is attributed to the buildup of fat deposits, which essentially clog up the heart's arteries. These deposits are called atheroma or plaque. Plaque is built up over time in the inner lining of the arteries, which limits the blood and oxygen flow and supply to the heart. The disease can occur in any artery, but most commonly it occurs in the aorta, the artery that receives blood directly from the heart. ASCVD can lead to angina pectoris, heart attack, and cardiac arrest.
About Bempedoic Acid
Bempedoic acid is a convenient, complementary, consistent, once-daily, oral LDL-C lowering drug that significantly reduces elevated LDL-C levels in patients with hypercholesterolemia, including patients inadequately treated with current lipid-modifying therapies. Bempedoic acid, a first-in-class, non-statin, targeted therapy, works in the liver to block cholesterol biosynthesis. Completed Phase-1 and 2 studies conducted in around 1,300 patients, and more than 800 patients treated with bempedoic acid, have produced LDL-C lowering results of up to 30% as monotherapy, 50% in combination with ezetimibe, and an incremental 20+% when added to stable statin therapy.
About Esperion Therapeutics, Inc.
Founded in 2008 and headquartered in Ann Arbor, Michigan, Esperion is the Lipid Management Company that specializes in developing and commercializing non-statin, convenient, complementary, consistent, once-daily, oral therapies for the treatment of patients with elevated LDL-C.
Stock Performance Snapshot
March 08, 2018 - At Thursday's closing bell, Esperion Therapeutics' stock dropped 4.13%, ending the trading session at $73.14.
Volume traded for the day: 809.98 thousand shares, which was above the 3-month average volume of 611.69 thousand shares.
Stock performance in the last month – up 8.45%; previous three-month period – up 24.71%; past twelve-month period – up 114.99%; and year-to-date - up 11.09%
After yesterday's close, Esperion Therapeutics' market cap was at $1.89 billion.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.6% at the end of the session.
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