Hearts & Minds Blog

AHA 2014 Scientific Sessions: IMPROVE-IT Results Reported and What They Mean for the Future of ETC-1002

Tim Mayleben

President and Chief Executive Officer

Marianne Andreach

Senior Vice President, Strategic Marketing and Product Planning

Last month, the American Heart Association (AHA) held its annual Scientific Sessions in Chicago, IL where presenters and attendees gathered from more than 105 countries to present cutting edge breakthroughs in cardiovascular science and research.  Esperion colleagues have attended and participated in Scientific Sessions for many years and always look forward to seeing and hearing first-hand the breaking news from presenters with the same focus that we have – to reduce cardiovascular disease risk and improve the lives of people around the world.

This year’s AHA Scientific Sessions were especially important!  The long awaited and highly anticipated results from the IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) study were reported early Monday morning.  Surprising all of the critics, the IMPROVE-IT results were positive and as we heard from many in attendance, convincingly re-affirmed the LDL-cholesterol lowering hypothesis, especially non-statin lowering of LDL-cholesterol.  The LDL-cholesterol lowering “hypothesis” is that lowering LDL-cholesterol results in a reduction of cardiovascular disease risk.  What is not as well known is that the LDL-cholesterol lowering hypothesis has been proven time and again over the past 30 years with different therapies to lower LDL-cholesterol dating back to 1984.  We found the IMPROVE-IT results especially gratifying because we have always believed in the LDL-cholesterol lowering hypothesis.

The positive IMPROVE-IT study results were important to Esperion and ETC-1002 since they once-again reaffirmed the LDL-cholesterol lowering hypothesis – and our belief that lowering LDL-cholesterol will continue to serve as a well-accepted surrogate marker for cardiovascular disease risk reduction among physicians, KOLs, and regulators.  It’s also important to note that the IMPROVE-IT study was the first to demonstrate that incremental LDL-cholesterol lowering on top of a statin results in further reductions in cardiovascular disease risk.

Almost 80 million people in the US have hypercholesterolemia and, of those, approximately 40 million are taking some type of LDL-cholesterol lowering therapy.  Despite the availability of statins, ezetimibe, and other therapies, approximately 13 million patients in the US are not at their LDL-cholesterol goal and need additional therapies to get to goal.  With the recent positive results from our Phase 2b 008 clinical study which showed that ETC-1002 lowers LDL-cholesterol by up to 30% as mono therapy and almost 50% in combination with ezetimibe, we remain confident that ETC-1002 can play an important role in cost-effectively and conveniently providing LDL-cholesterol lowering to patients with hypercholesterolemia, including those with statin intolerance – a patient population with an especially high unmet medical need.

We remain committed to our goal of bringing ETC-1002 to the market for the millions of patients in need of new, oral, well-tolerated therapies to lower their LDL-cholesterol and potentially reduce their cardiovascular disease risk.  We look forward to keeping you updated on our continued progress as we advance ETC-1002 into Phase 3 development in 2015!