Esperion Therapeutics Inc (NASDAQ:ESPR), a pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with hypercholesterolemia, today announced the start of a global Phase 3 long-term safety and tolerability study (ETC-1002-040) of bempedoic acid in patients with hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins. This study will enable the Company to understand the 52 week safety profile of bempedoic acid, and top-line results are expected in the fourth quarter of 2017.
ETC-1002-040 is a Phase 3 randomized, multicenter, double-blind, placebo-controlled study evaluating 180 mg of bempedoic acid versus placebo in 900 patients with hyperlipidemia at high cardiovascular disease risk and whose LDL-C is not adequately controlled with maximally tolerated lipid-modifying therapy. The study will enroll patients at approximately 125 sites in the U.S., Canada and the European Union. The primary objective is to assess safety and tolerability of patients treated with bempedoic acid for 52 weeks. Secondary objectives include assessing the effects of bempedoic acid on other lipid and cardiometabolic risk markers, including LDL-C and high-sensitivity C-reactive protein.
This study marks the launch of the Phase 3 clinical program — known as Cholesterol Lowering via ETC-1002, an ACL-inhibiting Regimen (CLEAR) — which will be focused on the development of bempedoic acid for statin intolerant patients with uncontrolled LDL-C levels. The Company will provide details of the full Phase 3 global development strategy in the second quarter of 2016. Separately, the Company anticipates formalizing and communicating the design of the planned cardiovascular outcomes trial in the second quarter of 2016.
“We are pleased to announce the launch of our Phase 3 program, CLEAR, with the initiation of this long-term safety study,” said Tim M. Mayleben, president and chief executive officer of Esperion. “We continue to make progress with regulatory authorities to finalize the Phase 3 global development strategy, and data from this study will help confirm the safety profile of bempedoic acid over the long term, which is foundational for this program.”
Esperion’s Commitment to Cardiometabolic Disease
Esperion is committed to improving the lives of patients with hypercholesterolemia by developing therapies to lower LDL-C. Esperion scientists discovered bempedoic acid and the LDL-C lowering therapy is in late stage development. Esperion plans to develop both bempedoic acid and a fixed dose combination of bempedoic acid and ezetimibe with a particular focus on patients with hypercholesterolemia who are considered intolerant of statin therapy. It is estimated that approximately 10% of patients who are prescribed statins, 3.5 million patients in the U.S., are considered statin intolerant. (Original Source)
Shares of Esperion Therapeutics closed yesterday at $16.48. ESPR has a 1-year high of $120.96 and a 1-year low of $15.50. The stock’s 50-day moving average is $23.86 and its 200-day moving average is $43.24.
On the ratings front, Esperion has been the subject of a number of recent research reports. In a report issued on January 8, Chardan analyst Gbola Amusa MD CFA reiterated a Hold rating on ESPR, with a price target of $18, which represents a potential upside of 9.2% from where the stock is currently trading. Separately, on December 15, RBC’s Michael Yee reiterated a Buy rating on the stock and has a price target of $40.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Gbola Amusa MD CFA and Michael Yee have a total average return of -4.3% and -1.0% respectively. CFA has a success rate of 41.6% and is ranked #3096 out of 3609 analysts, while Yee has a success rate of 47.9% and is ranked #2529.
The street is mostly Bullish on ESPR stock. Out of 7 analysts who cover the stock, 6 suggest a Buy rating and one recommends to Hold the stock.
Esperion Therapeutics Inc is engaged in the research, development and commercialization of therapies for the treatment of patients with elevated levels of elevated levels of LDL-C.