Esperion Therapeutics Inc (NASDAQ:ESPR) announced the initiation of the global cardiovascular outcomes trial (CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and considered “statin intolerant.”
The CVOT — known as Cholesterol Lowering via BEmpedoic Acid, an ACL-inhibiting Regimen (CLEAR) Outcomes — is an event-driven, global, randomized, double-blind, placebo-controlled study expected to enroll approximately 12,600 patients with hypercholesterolemia and high CVD risk at more than 600 sites in approximately 30 countries. The study is expected to enroll over a 30-month period with a total estimated study duration of approximately 4.75 years. The expected average treatment duration will be 3.5 years with a minimum treatment duration of approximately 2.25 years. Patients enrolling in the study will be required to have a history of, or be at high-risk for, CVD with LDL-C levels between 100 mg/dL and 190 mg/dL despite background lipid-lowering therapy, resulting in an expected average baseline LDL-C level in all patients of approximately 135 mg/dL.
“The start of the CLEAR Outcomes CVOT is one of the last and most exciting steps in the development of bempedoic acid, and we are very pleased to have begun dosing patients,” said Tim M. Mayleben, president and chief executive officer of Esperion. “We worked closely with Dr. Steven Nissen and the team at the Cleveland Clinic to develop this well-powered study to demonstrate the potential benefit of bempedoic acid in reducing events in a patient population with a significant unmet need — patients with hypercholesterolemia considered ‘statin intolerant’ who are at high-risk for CVD. We believe bempedoic acid has the potential to provide a well-tolerated, complementary, once-daily, oral therapy for patients with ‘statin intolerance’ and other high-risk patient populations with hypercholesterolemia.”
The primary efficacy endpoint of the event-driven global study is the effect of bempedoic acid versus placebo on the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, or coronary revascularization; also referred to as “five-component MACE”). Similar to other CVOTs, CLEAR Outcomes is designed to provide greater than 85 percent power to detect an approximately 14 percent relative risk reduction in the primary endpoint in the bempedoic acid treatment group as compared to the placebo group, and is expected to complete with a minimum of 1,437 patients experiencing the primary endpoint.
The Company expects to submit a New Drug Application (NDA) for cardiovascular risk reduction to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), on the basis of a successful completion of the CLEAR Outcomes CVOT, by 2022. (Original Source)
Shares of Esperion Therapeutics closed last Friday at $13.78. ESPR has a 1-year high of $20.19 and a 1-year low of $9.40. The stock’s 50-day moving average is $12.25 and its 200-day moving average is $11.78.
On the ratings front, Esperion Therapeutics has been the subject of a number of recent research reports. In a report issued on December 29, RBC analyst Michael Yee reiterated a Hold rating on ESPR, with a price target of $15, which implies an upside of 9% from current levels. Separately, on December 20, Credit Suisse’s Vamil Divan downgraded the stock to Sell and has a price target of $12.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Yee and Vamil Divan have a yearly average loss of -5.1% and a return of 11.4% respectively. Yee has a success rate of 42% and is ranked #4111 out of 4350 analysts, while Divan has a success rate of 57% and is ranked #365.
Overall, one research analyst has rated the stock with a Sell rating, 3 research analysts have assigned a Hold rating and 3 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $12.00 which is -12.9% under where the stock closed last Friday.
Esperion Therapeutics, Inc. is a clinical stage biopharmaceutical company, which focuses on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers. The company operates through one segment, which is the business of researching, developing and commercializing therapies for the treatment of patients with elevated LDL-C.