MUNICH–(BUSINESS WIRE)–Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced results from two pooled analyses from four Phase 3 clinical trials for bempedoic acid and separate results from a Phase 2 study of the bempedoic acid / ezetimibe fixed dose combination (FDC). The data were presented at the American College of Cardiology’s 69th Scientific Sessions Together with World Congress of Cardiology virtual experience (ACC.20/WCC).
The 12-week Phase 2 bempedoic acid / ezetimibe FDC study (also known as Study 058) enrolled adult patients with type 2 diabetes mellitus (T2DM) at high risk of cardiovascular disease.6 The bempedoic acid / ezetimibe FDC reduced LDL-C by 40% compared to placebo with no increase in glycated haemoglobin (HbA1c), indicating that glycaemic control was not adversely affected.6 The bempedoic acid / ezetimibe FDC was well tolerated in Study 058, and the incidence of adverse events rates were generally comparable to placebo.6
The first pooled analysis of four Phase 3 clinical trials investigating bempedoic acid in adult patients with hypercholesterolaemia demonstrated that bempedoic acid resulted in a significant lowering of LDL-C, in addition to other lipid measurements (total cholesterol, non-high-density lipoprotein cholesterol (HDL-C) apoliopoprotein B, HDL-C), regardless of the presence of background ezetimibe.7 The use of bempedoic acid with or without background ezetimibe therapy, was in the same range for overall incidence of treatment emergent adverse events (TEAEs) in both study arms.7
The second pooled analysis showed that bempedoic acid lowers high sensitivity C-reactive protein (hsCRP), a key marker of inflammation associated with cardiovascular disease, by 42% at 12 weeks in patients with hypercholesterolaemia, regardless of the presence or intensity of background statin therapy.8
“We are encouraged by all the data presented today that continue to demonstrate the potential benefit of bempedoic acid for adult patients who need to reduce their LDL-C levels in order to reduce their risk of a cardiovascular event such as a heart attack or stroke,” said Wolfgang Zierhut, MD, Head of Antithrombotic and Cardiovascular Medical Affairs Department at Daiichi Sankyo Europe. “There is a need to reduce LDL-C levels as identified in the most recent ESC/EAS guidelines and the Phase 2 data presented today showing the potential to lower LDL-C for people at particularly high risk due to their diabetes without impacting glycaemic control is promising to see, however we will need validation from larger studies. Additional lipid-lowering treatments are badly needed to support patients, and we hope to be able to make bempedoic acid available in Europe soon.”
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About bempedoic acid
With a unique mechanism of action, bempedoic acid is being developed as a first-in-class, affordable, oral treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.1,2,3,4 Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver.1,2,3,4
Bempedoic acid has received a positive CHMP recommendation for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:1,2,3,4
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Bempedoic acid acts on the well-known cholesterol synthesis pathway, upstream of the statin target in the liver, with a unique mechanism of action which allows additional LDL-C lowering when added to statin treatment.9 Due to its novel mechanism of action, bempedoic acid is not activated in skeletal muscle.9
About bempedoic acid / ezetimibe
Bempedoic acid / ezetimibe is being developed as an oral treatment which combines two complementary ways of reducing cholesterol in a convenient once-daily tablet.5 Bempedoic acid / ezetimibe is a fixed dose combination tablet.5
Bempedoic acid / ezetimibe has received a positive CHMP recommendation for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:5
- in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe,
- alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,
- in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without a statin.
Daiichi Sankyo Europe has licensed exclusive commercialisation rights to bempedoic acid and bempedoic acid / ezetimibe in the European Economic Area and Switzerland from Esperion. Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world.
1 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.
2 Ray KK, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019; 380:1022–32.
3 Goldberg AC, et al. Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease. The CLEAR Wisdom Randomized Clinical Trial. JAMA. 2019;322(18):1780–1788. doi:10.1001/jama.2019.16585.
4 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.
5 Ballantyne, CM, et al. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2019; doi 10.1177/2047487319864671.
6 Bays, HE, et al. Bempedoic acid 180 mg + ezetimibe 10 mg fixed dose combination drug product vs ezetimibe alone or placebo in patients with type 2 diabetes and hypercholesterolemia. Poster presentation at American College of Cardiology’s 69th Scientific Sessions Together with World Congress of Cardiology virtual experience (ACC.20/WCC). March 2020.
7 Catapano, AL, et al. Bempedoic acid efficacy and safety in patients at high-risk for CVD treated with or without ezetimibe: pooled analysis of 4 phase 3 clinical trials. Poster presentation at American College of Cardiology’s 69th Scientific Sessions Together with World Congress of Cardiology virtual experience (ACC.20/WCC). March 2020.
8 Stroes, ESG, et al. Factors influencing bempedoic acid-mediated reductions in high sensitivity c-reative protein: analysis of pooled patient-level data from 4 phase 3 clinical trials. Poster presentation at American College of Cardiology’s 69th Scientific Sessions Together with World Congress of Cardiology virtual experience (ACC.20/WCC). March 2020.
9 Pinkosky SL, et al. Liver- specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nature Communications. 2016; 7:13457. DOI:10.1038/ncomms13457.