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Esperion Therapeutics (ESPR) Phase 3 Long-Term Safety Study of Bempedoic Acid Meets Primary Endpoint

May 2, 2018 7:31 AM EDT

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Esperion (NASDAQ: ESPR), the Lipid Management Company focused on developing and commercializing complementary, convenient, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced positive top-line results from the second pivotal, Phase 3 study (Study 1 or 1002-040), the long-term safety study of bempedoic acid 180 mg, in this case evaluating the safety, tolerability and efficacy of bempedoic acid versus placebo in high-risk patients with atherosclerotic cardiovascular disease (ASCVD) who are inadequately controlled with current lipid-modifying therapies, including maximally tolerated statin therapy.

The study included 2,230 patients and met the primary endpoint of safety and tolerability and the key efficacy endpoint with on-treatment LDL-C lowering of an additional 20 percent at twelve weeks (p<0.001) (18 percent (p<0.001) in the intent to treat analysis). Patients treated with bempedoic acid also achieved a significant reduction of 22 percent in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease.

“We know from the Phase 2 program that bempedoic acid demonstrates consistent and complementary LDL-cholesterol lowering and hsCRP reductions when added to currently available therapies. As expected, these new data confirm the long-term safety and tolerability profile of bempedoic acid, even in high cardiovascular risk patients on maximally tolerated statins, especially when looking at muscle-related adverse events,” said Christie M. Ballantyne, M.D., chairman of Esperion’s Phase 3 Executive Committee and Professor and Chief of Cardiology at Baylor College of Medicine in Houston. “Physicians are in need of additional convenient, once-daily, oral therapies, such as bempedoic acid, to complement currently available, once-daily, oral therapies for patients with ASCVD. These results suggest that bempedoic acid could be an important new oral treatment option for a very broad range of patients.”

Long-Term Safety and Tolerability of Bempedoic Acid over 52 Weeks

In this 52-week study, bempedoic acid was observed to be safe and well-tolerated. There were no clinically relevant differences between the bempedoic acid and placebo groups in the occurrence of adverse events (AEs) with 78.5 percent and 78.7 percent, respectively; or serious adverse events (SAEs) with 14.5 percent and 14.0 percent, respectively. Discontinuations due to AEs were 10.9 percent and 7.1 percent, respectively for the bempedoic acid and placebo groups; discontinuations due to muscle-related AEs were 2.2 percent and 1.9 percent, respectively in the bempedoic acid and placebo groups. In the study, 0.54 percent of patients treated with bempedoic acid and 0.13 percent of patients in the placebo group had elevations in liver function tests (ALT/AST) of greater than three times the upper limit of normal, repeated and confirmed. The cumulative number of patients now treated with bempedoic acid in Phase 2 and Phase 3 clinical trials totals 2,434. Of these, 0.58 percent had elevations in liver function tests greater than three times the upper limit of normal, repeated and confirmed. This rate of elevations in liver function test is consistent with the rate observed in all other previously approved oral LDL-C-lowering therapies, including statins and ezetimibe.

A chart accompanying this announcement is available at http://resource.globenewswire.com/Resource/Download/0e68b138-3934-4d94-a1db-1261db1939e3

“In this study, the largest in our Phase 3 program, bempedoic acid was observed to be safe and well tolerated over a 52-week period, while providing clinically and statistically significant LDL-cholesterol lowering and reductions in hsCRP when added on to maximally tolerated statin therapy,” said Tim M. Mayleben, president and chief executive officer of Esperion. “In the coming months, results from our three remaining pivotal Phase 3 studies are expected to further validate the safety, efficacy and tolerability profile of bempedoic acid and the bempedoic acid / ezetimibe combination pill, definitively establishing these once-daily oral therapies as convenient and complementary to existing treatments for the 13 million people in the U.S. with ASCVD who live with elevated levels of LDL-cholesterol despite taking maximally-tolerated lipid-modifying therapy and remain at high risk for further cardiovascular disease or events, including heart attack and stroke.”

LDL-C Lowering and hsCRP Reduction

The study met its key efficacy endpoint with on-treatment LDL-C lowering of 20 percent at 12 and 24 weeks, and 16 percent at 52 weeks (p<0.001). The LDL-C lowering for the bempedoic acid group at 12 weeks was 18 percent from baseline, as compared to an LDL-C increase of two percent for the placebo group. The intent to treat LDL-C lowering totaled 18 percent (p<0.001) at 12 weeks. These results were comparable across statin treatment groups. Patients treated with bempedoic acid also achieved a significant reduction of 22 percent in hsCRP, compared to the placebo group which had an increase of three percent (p<0.001).

A chart accompanying this announcement is available at http://resource.globenewswire.com/Resource/Download/32365f89-f291-42ef-8ffa-3474acba6461

Esperion plans to present full results from this study at an upcoming medical conference and to publish in a major medical journal. Design of Global Pivotal Phase 3 Study 1 (1002-040) The 52-week, global, pivotal Phase 3 randomized, double-blind, placebo-controlled, multicenter study evaluated the long-term safety and tolerability of bempedoic acid 180 mg/day versus placebo in high-risk patients with ASCVD and/or heterozygous familial hypercholesterolemia (HeFH). LDL-C levels of at least 70 mg/dL who are inadequately controlled with current lipid-modifying therapies, including maximally tolerated statin therapy. The study was conducted at 117 sites in the U.S., Canada and Europe. A total of 2,230 patients were randomized 2:1 to receive bempedoic acid or placebo. The secondary objective was to assess the 12-week LDL-C lowering efficacy of bempedoic acid versus placebo. Tertiary objectives were to assess the effect of bempedoic acid on other lipid parameters and risk markers, including hsCRP.

An open-label extension study (1002-050) was initiated in early 2017 and is fully enrolled with 1,462 patients.

Conference Call and Webcast Information Esperion's lipid management team will host a conference call and webcast today, Wednesday, May 2, 2018, at 8:30 a.m. Eastern Time to discuss these Phase 3 study results. The call can be accessed by dialing (877) 312-7508 (domestic) or (253) 237-1184 (international) five minutes prior to the start of the call and providing access code 8390264. A live audio webcast can be accessed on the investors and media section of the Esperion website at investor.esperion.com. Access to the webcast replay will be available approximately two hours after completion of the call and will be archived on the Company's website for approximately 90 days.



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