ESPR is now up 20 percent ($8.83) on the day, to $54.14.
Here's the second of today's ESPR stories. It's about the benefits of Bempedoic Acid - which has always been one of my favorite investigational inhibitors. (lol)
August 8, 2017
Esperion Provides Bempedoic Acid Franchise Development Program Updates; Reports Second Quarter 2017 Financial Results
GlobeNewswire
– Phase 3 Enrollment Progress Supports NDA Submissions for LDL-C Lowering Indications for Bempedoic
Acid / Ezetimibe Combination Pill and Bempedoic Acid by the First Quarter 2019 –
– Conference Call and Webcast on Tuesday, August 8, 2017 at 8:30 a.m. Eastern Time –
ANN ARBOR, Mich., Aug. 08, 2017 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (ESPR), the Lipid Management Company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today provided bempedoic acid franchise development program updates, and financial results for the second quarter ended June 30, 2017. The company now expects to submit two New Drug Applications (NDAs) for LDL-C lowering indications for the bempedoic acid / ezetimibe combination pill and bempedoic acid by the first quarter of 2019.
Bempedoic Acid Global Pivotal Phase 3 Program Update
The ongoing Phase 3 program for bempedoic acid includes four global pivotal studies expected to enroll approximately 3,400 high CVD risk patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), or who are high risk primary prevention, on optimized background lipid-modifying therapy and with elevated levels of LDL-C. These patients are on two distinct types of background lipid-modifying therapy: 1) patients on their maximally tolerated statin therapy, and 2) patients only able to tolerate less than the lowest approved daily starting dose (e.g., patients considered statin intolerant).
Global Pivotal Phase 3 Study 1: This 52-week long-term safety and tolerability study was initiated in January 2016 and fully enrolled in January 2017 with 2,230 patients with ASCVD and/or HeFH whose LDL-C is not adequately controlled with current lipid-modifying therapies, and who are taking maximally tolerated statin therapy. Top-line results are expected to be announced by the second quarter of 2018.
Global Pivotal Phase 3 Study 2: This 52-week LDL-C lowering efficacy and safety study was initiated in December 2016 and will be fully enrolled mid-month with approximately 750 patients with ASCVD and/or HeFH whose LDL-C is not adequately controlled with current lipid-modifying therapies, and who are taking maximally tolerated statin therapy. Top-line results are expected to be announced by the third quarter of 2018.
Global Pivotal Phase 3 Study 3: This 24-week LDL-C lowering efficacy study was initiated in December 2016 and will be fully enrolled this month with approximately 300 high CVD risk patients with ASCVD and/or HeFH, or who are high risk primary prevention, whose LDL-C is not adequately controlled with current lipid-modifying therapies, and who are only able to tolerate less than the lowest approved daily starting dose of a statin and considered statin intolerant. Top-line results are expected to be announced by the second quarter of 2018.
Global Pivotal Phase 3 Study 4: This 12-week LDL-C lowering efficacy study was initiated in December 2016 and will be fully enrolled in September with approximately 225 high CVD risk patients with ASCVD and/or HeFH, whose LDL-C is not adequately controlled with current lipid-modifying therapies, including ezetimibe, and who are only able to tolerate the lowest approved daily starting dose of a statin and considered statin intolerant. Top-line results are expected to be announced by the second quarter of 2018.
“I’m pleased with the progress our team has made enrolling patients in all of our global pivotal Phase 3 LDL-C lowering efficacy studies. We are on track to complete enrollment for the Phase 3 program this quarter, and look forward to reporting top-line results from each of the four global pivotal Phase 3 studies in the second and third quarters of 2018,” said Tim Mayleben, president and chief executive officer of Esperion Therapeutics. “The Phase 3 pivotal study enrollment progress, together with FDA confirmation of the regulatory pathways to approval for both the bempedoic acid / ezetimibe combination pill and bempedoic acid supports our plans to submit both NDAs for LDL-C lowering indications by the first quarter of 2019.”
http://finance.yahoo.com/news/esperion-provides-bempedoic-acid-franchise-120000252.html
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