Bempedoic Acid Lowers LDL-Cholesterol without Adversely Impacting Glycaemic Control in Pooled Analyses of Phase 3 Trials Presented at the American Heart Association 2019 Scientific Sessions

• Bempedoic acid is an oral, once-daily ATP citrate lyase (ACL) inhibitor that reduces cholesterol synthesis in the liver and is currently undergoing regulatory review
• Bempedoic acid lowered LDL-Cholesterol (LDL-C) in a manner complementary to other lipid-lowering therapies, including statins, in Phase 3 clinical trials[i]
• Pooled analyses include data from four Phase 3 trials which enrolled over 3,600 patients

MUNICH, Germany, (November 25, 2019) – Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced the results of two pooled analyses from four Phase 3 clinical trials of bempedoic acid which were presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia. Bempedoic acid is currently undergoing review for marketing authorisation by the European Medicines Agency (EMA) and by the United States Food and Drug Administration (FDA).

One presentation highlighted that bempedoic acid reduced haemoglobin A1c (HbA1c) by 0.19% (absolute difference) versus placebo in patients with diabetes at 12 weeks (mean change of -0.12% from 6.83% at baseline to 6.71% at week 12 in the bempedoic acid group and a mean change of 0.07% from 6.83% at baseline to 6.90% at week 12 in the placebo group).[ii]  HbA1c is a standard measure of glycaemic control used in diabetes management. The analysis also showed that patients on bempedoic acid had fewer instances of new-onset diabetes as well as hyperglycaemia than those on placebo.2 The pooled analysis suggests that bempedoic acid does not have an adverse impact on glycaemic control in patients with and without diabetes when added to a stable background of lipid lowering therapy.2

Another analysis found that across the four phase 3 studies, bempedoic acid significantly lowered low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolaemia when added on to maximally tolerated statin therapy.[iii]  In patients on background statin therapy, bempedoic acid lowered LDL-C by 18% compared to placebo (absolute change of -19.8 mg/dL from 107.7 mg/dL at baseline to 87.9 mg/dL at week 12 in the bempedoic acid group, compared to an absolute change of +0.3 mg/dL from 107.5 mg/dL at baseline to 107.8 mg/dL at week 12 in the placebo group).3^,[iv]  In patients not on statin background therapy, bempedoic acid lowered LDL-C by 25% compared to placebo (absolute change of -36.5 mg/dL from 146.0 mg/dL at baseline to 109.5 mg/dL at week 12 in the bempedoic acid group, compared to an absolute change of +0.6 mg/dL from 141.2 mg/dL at baseline to 141.8 mg/dL at week 12 in the placebo group).3^,4

Bempedoic acid is being developed as a cost-effective, convenient, once-daily, oral add-on treatment for people with hypercholesterolaemia who are unable to reach LDL-C goals after optimised oral lipid lowering therapies and remain at high risk of a cardiovascular event such as a heart attack or stroke.

“Many high- and very high-risk hypercholesterolaemia patients are also trying to keep their blood glucose under control. They may already have diabetes or be at risk of developing it. High cholesterol and high blood glucose are both important risk factors for cardiovascular disease and events such as a heart attack or stroke,” said said Wolfgang Zierhut, MD, Head of Antithrombotic and Cardiovascular Medical Affairs Department at Daiichi Sankyo Europe. “Evidence has shown that some lipid-lowering treatments can increase the risk of diabetes and so it is encouraging to see that bempedoic acid is lowering cholesterol on top of existing treatments with the potential of not negatively affecting glycaemic control.” 

[i] Laufs U, et al. Efficacy and Safety of Bempedoic Acid in Patients with Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019;8(7):e011662.

[ii] Abstract. Bempedoic acid and glycemic control: A pooled analysis of 4 phase 3 clinical trials. Presented at the American Heart Association 2019 Scientific Sessions.

[iii] Abstract. Efficacy of bempedoic acid: A pooled analysis of 4 pivotal phase 3 clinical trials. Presented at the American Heart Association 2019 Scientific Sessions.

[iv] Poster. Efficacy of bempedoic acid: a pooled analysis of 4 pivotal phase 3 clinical trials. Presented at the American Heart Association 2019 Scientific Sessions.

Bempedoic Acid

With a targeted mechanism of action, bempedoic acid is an oral, once-daily ATP Citrate Lyase (ACL) inhibitor that reduces cholesterol synthesis in the liver and thereby lowers circulating LDL-C levels.[v]^,[vi] It is intended for patients with hypercholesterolaemia and/or at high risk of atherosclerotic cardiovascular disease (ASCVD) who need additional LDL-C lowering despite maximally-tolerated statin therapy.

Bempedoic acid has a unique, innovative mode of action, which is complimentary to other lipid-lowering therapies, such as statins.1 Due to its liver-specific mode of action, bempedoic acid has a reduced potential to induce the muscle-related side-effects commonly associated with statin therapy and provide additional LDL-C lowering on top of statin monotherapy in clinical trials. Bempedoic acid has been observed to reduce high‐sensitivity C‐reactive protein (hsCRP), a key marker of inflammation associated with cardiovascular disease.6

Bempedoic acid (180 mg) and the bempedoic acid / ezetimibe FDC tablet (180 mg/10 mg) are currently under review by the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use and the U.S. Food and Drug Administration for LDL-C lowering in patients who are not yet at their target LDL-C level. Daiichi Sankyo Europe licensed exclusive commercialisation rights to these products in the European Economic Area and Switzerland from Esperion. Approval decisions are expected during the first half of 2020.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centred around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.

Contact

Lydia Worms (Europe)

Daiichi Sankyo Europe GmbH

Communications & Product PR Europe

+49 (89) 7808751

[v] Ray KK, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019;380:1022–32.

[vi] Ballantyne CM, et al. Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study. Atherosclerosis.2018;277:195–203.