World News: 12:00 GMT Wednesday 11th September 2019. [Daiichi Sankyo via Businesswire via SPi World News]
Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced the completion of patient enrolment in the CLEAR cardiovascular outcomes trial. The trial is designed to evaluate whether treatment with bempedoic acid reduces the risk of cardiovascular events in patients who have, or are at high risk for, cardiovascular disease and have a prior adverse event history with statins that limit the use or dose of statin therapy.
CLEAR Outcomes is an event-driven trial and will conclude once the pre-determined number of primary cardiovascular endpoints occur; this is estimated to occur during the second half of 2022. Bempedoic acid and its fixed dose combination (FDC) tablet with ezetimibe are currently undergoing regulatory review for marketing authorisation by the European Medicines Agency (EMA) and by the United States Food and Drug Administration (FDA).
“We are excited by the potential of bempedoic acid to help provide cardiovascular protection for people struggling to achieve low-density lipoprotein (LDL) cholesterol targets,” said Wolfgang Zierhut, MD, Head of Antithrombotic and Cardiovascular Medical Affairs Department at Daiichi Sankyo Europe. “The CLEAR Outcomes trial is a significant undertaking which will provide important information on how the LDL cholesterol lowering seen with bempedoic acid translates into an impact on cardiovascular risk.”
“Phase 3 clinical trials demonstrated that bempedoic acid produces clinically important reductions in LDL cholesterol as well as hsCRP, a key marker of inflammation associated with cardiovascular disease,” said Stephen Nicholls, MBBS, PhD, FRACP, FACC, FESC, FAHA, FCSANZ, co-principal investigator of CLEAR Outcomes, and Director of MonashHeart, Monash Health and Professor of Cardiology, Monash University. “The CLEAR cardiovascular outcomes trial builds on these results and will determine whether bempedoic acid can also reduce the risk of cardiovascular morbidity and mortality. Treatment of statin averse patients, like those enrolled in CLEAR Outcomes, represents a major unmet medical need that affects millions of patients.”
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Design of the CLEAR cardiovascular outcomes trial
CLEAR Outcomes is a Phase 3, event-driven, randomised, multicenter, double-blind, placebo-controlled trial designed to evaluate whether treatment with bempedoic acid reduces the risk of cardiovascular events. The primary endpoint of the study is the effect of bempedoic acid on major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularisation; also referred to as "four-component MACE"). CLEAR Outcomes is designed to provide 90% power to detect an approximately 15% relative risk reduction in the primary endpoint in the bempedoic acid treatment group as compared to the placebo group and is expected to complete with a minimum of 1,620 patients experiencing the primary endpoint.
Eligible patients at high risk (LDL-C >100 mg/dL in primary prevention) for cardiovascular disease or with cardiovascular disease (LDL-C between 100 mg/dL to 190 mg/dL in secondary prevention) and who are only able to tolerate less than the lowest approved daily starting dose of a statin were randomised to receive bempedoic acid 180 mg once-daily or placebo. The study enrolled 14,032 patients at over 1,200 sites in 32 countries.
For more information, go to clinicaltrials.gov:.
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.1,2 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.3 Due to its liver-specific mode of action, bempedoic acid has a reduced potential to induce the muscle-related side-effects associated with statin therapy and provide additional LDL-C lowering on top of statin monotherapy in clinical trials.2
Completed Phase 2 and Phase 3 studies conducted in almost 4,800 patients, and approximately 3,100 patients treated with bempedoic acid, have demonstrated: an additional 20% LDL-C lowering (placebo-corrected) when added to moderate-to-high intensity statin background treatment; 28% LDL-C lowering (placebo-corrected) when added to no-or-low intensity statin background treatment; up to 38% (placebo-corrected) LDL-C lowering when administered as a fixed dose combination with ezetimibe in patients on maximally tolerated statin therapy.1,2,4
Bempedoic acid (180 mg) and the bempedoic acid / ezetimibe fixed dose combination 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.
Bempedoic Acid / Ezetimibe FDC:
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 centered around rare diseases and immune disorders. For more information, please visit:.
1 Ray KK, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019;380:1022–32.
2 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.
3 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.
4 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.
Business Wire: 12:00 GMT Wednesday 11th September 2019
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