Bempedoic Acid Significantly Reduces LDL-Cholesterol on Top of Statin Therapy: Results of the CLEAR Wisdom Trial, Published in the Journal of the American Medical Association
Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced the publication of results from the Phase 3 CLEAR Wisdom trial in the Journal of the American Medical Association (JAMA).1 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).
CLEAR Wisdom, a Phase 3, double-blind, randomised trial, evaluated the efficacy, long-term safety and tolerability of bempedoic acid 180 mg versus placebo in 779 patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolaemia (HeFH) inadequately controlled with current lipid-modifying therapies, added on to maximally-tolerated statin therapy, which may mean no statin at all.1
The JAMA publication includes results for the primary efficacy endpoint of low-density lipoprotein cholesterol (LDL-C) lowering at 12 weeks and key secondary endpoints of safety and tolerability over 52 weeks. The publication reports that bempedoic acid:1
- significantly lowered LDL-C by 17% on background maximally-tolerated statin therapy at 12 weeks, with nearly all patients (85%, 444/522 ) on moderate- or high-intensity statins, and the effect was durable through 52 weeks;
- significantly lowered high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, by 19%, and the effect was durable through 52 weeks;
- showed no worsening of haemoglobin A1c (HbA1c) (- 0.21% vs. placebo) in patients with diabetes at 12 weeks;
- showed overall adverse event rates comparable with placebo (bempedoic acid 70% 366/522 vs. placebo 71% 182/257) at 52 weeks, and the proportion of patients with reported serious adverse events was similar compared with placebo (bempedoic acid 20% 106/522 vs. placebo 19% 48/257) at 52 weeks;
- showed adjudicated three-component major adverse cardiac event rates of 2.7% (14/522) with bempedoic acid and 4.7% (12/257) with placebo.
“The CLEAR Wisdom trial demonstrated that bempedoic acid provided additional LDL-C lowering in patients on background maximally-tolerated statin therapy and had an overall adverse event profile that was comparable to placebo,” said Anne C. Goldberg MD, FACP, FAHA, FNLA, Professor of Medicine, Division of Endocrinology, Metabolism and Lipid Research at Washington University, St. Louis and lead study author. “These results are consistent with the results reported from the largest long-term Phase 3 study of bempedoic acid, Study 1 or CLEAR Harmony, which were published earlier this year in the New England Journal of Medicine. Results across the Phase 3 development programme show that bempedoic acid has the potential to be a treatment option for high-risk patients who require additional LDL-C lowering.”
“We believe that bempedoic acid will address an important unmet need for patients who require additional LDL-C lowering and are not reaching their goals with existing oral lipid lowering therapies,” said Wolfgang Zierhut, MD, Head of Antithrombotic and Cardiovascular Medical Affairs Department at Daiichi Sankyo Europe. “Many patients remain at high risk of a cardiovascular event and need additional treatment options to achieve LDL-C goals. This is even more pertinent given that the latest guidelines suggest even lower LDL-C goals to provide optimal protection.”
- ENDS -
Design of Global Pivotal Phase 3 Study 2 (1002-047, also known as CLEAR Wisdom)
The 52-week, global, pivotal Phase 3 randomised, double-blind, placebo-controlled, multi-centre study evaluated the efficacy and safety of bempedoic acid 180 mg/day versus placebo. The study was conducted at 86 sites in North America and Europe. A total of 779 patients were randomised 2:1 to receive bempedoic acid or placebo. The primary efficacy objective was to assess the 12-week LDL-C lowering efficacy of bempedoic acid versus placebo. Secondary objectives included evaluating the safety and tolerability of bempedoic acid versus placebo, the 24-week and 52-week LDL-C lowering efficacy of bempedoic acid versus placebo, and bempedoic acid’s effects on other risk markers after 12 weeks of treatment, including hsCRP and HbA1c, versus placebo.
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.2,3 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.4 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.3
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.
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.
1 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.
2 Ray KK, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019;380:1022–32.
3 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.
4 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.
Lydia Worms (Europe)
Daiichi Sankyo Europe GmbH
Communications & Product PR Europe
+49 (89) 7808751
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Sabio Group Acquires Coverage Group in France6.7.2020 11:00:00 EEST | Press release
Sabio Group has announced the acquisition of Coverage Group, one of France’s leading independent providers of customer experience and communications technology solutions. The acquisition supports Sabio’s goal of becoming the leading player across the European CX market and will add significant scale to the company’s French operations. Formed in 2007, Paris-based Coverage Group is an established Genesys Gold, Avaya Edge, Oracle Gold and Broadsoft technology partner. The company has a proven track record in helping organisations across France to place cloud-based customer experience solutions at the heart of their digital strategy, with customers including ENGIE, BEA, EBP, Emil Frey, Homeserve, NutriXo, Optimind, Pierre Fabre, Pierre & Vacances, Sitel and Teleperformance. “The acquisition is a massively important strategic addition for Sabio Group and our customers in a number of ways – it means we have now built a substantial presence and customer base in France, it further strengthens
BearingPoint helps government and public sector organizations deliver critical health and public services during the Covid-19 pandemic6.7.2020 10:00:00 EEST | Press release
Management and technology consultancy BearingPoint announced today that it is helping its government and public sector clients across Europe to deliver critical health and public services during the Covid-19 pandemic through new delivery models, new ways of working, digitalization, and automation. “BearingPoint’s organization as a single, European-based business has meant we have been able to draw on capabilities, leading practices and learnings from across our government and public sector clients and teams in many different countries. Working remotely and in partnership with our clients, we have quickly mobilized resources to design and deliver solutions to support both the public services needed during Covid-19 and the new ways of working for public servants,” said Andrew Montgomery, Partner and Global Leader Government and Public Sector at BearingPoint. New delivery models and services People’s health and well-being during the Covid-19 crisis have required public services to rapidly
DNA Selects VisualOn’s OnStream® Android TV to Deliver the Highest Quality of Service for Their Over the Top (OTT) Deployment on the Android TV Platform6.7.2020 09:00:00 EEST | Press release
VisualOn, Inc., a streaming software provider that enables scalable, cross-platform media playback for leading video services, today announced that the company is now providing DNA's end users the ability to stream the highest quality video using the Android TV. DNA is Finland's largest cable operator. Launched in February this year, the new DNA TV has revamped DNA’s TV offering for IP-based delivery, introducing multiple features including unlimited NPVR recordings, a new user interface and improved video stream quality. Through its innovative program-centric approach, subscribers can view and record unlimited TV programs with unprecedented ease of use and watch live and VOD content whenever they want, anywhere in the EU via the DNA TV app. Furthermore, the service delivers compelling content recommendations based on users’ individual viewing preferences. VisualOn, powered by AWS, has closely supported DNA to build and deploy this platform. “Service reliability and a seamless user exp
Excelya Welcomes Three European Contract Research Organizations to Become One Stop Provider Throughout Europe6.7.2020 09:00:00 EEST | Press release
Today, Excelya, a leading contract research organization (CRO) specializing in clinical research, announced that three European CROs joined Excelya Group: Zeincro based in Central-Eastern & Southern Europe, The Clinical Company based in the Netherlands and Belgium and Koehler eClinical based in Germany. Together, they will be known as Excelya Group. This alliance will allow Excelya to offer a one stop provider service model throughout Europe for its clients, whether they need full service, functional service providing or consulting services. Zeincro is a leading contract research organization primarily operating in Central-Eastern & Southern Europe with particular expertise in clinical operations, safety and medical affairs. The Clinical Company is present in the Belgian and Dutch markets specializing in clinical operations. Koehler eClinical is a German specialty CRO with a focus on biostatistics and data solutions. Thanks to the unification with these three companies, Excelya Group i
EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer6.7.2020 09:00:00 EEST | Press release
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. Trastuzumab deruxtecan was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Validation confirms that the application is complete and commences the scientific review process by the EMA’s CHMP. Accelerated assessment is granted by the CHMP to products expected to be of major interest for public health and therapeutic innovation and can significantly reduce the review timelines. “The accelerated assessment highlights the significant unmet need for patients with HER2 positive metastatic breast cancer that trastuzumab deruxtecan aims at addressing
Study Investigates Accuracy of Respiration Rate Obtained From Pulse Oximetry on Pediatric Patients Using Masimo RRp®6.7.2020 09:00:00 EEST | Press release
Masimo (NASDAQ: MASI) today announced the results of a study published in Pneumonia in which independent researchers in New Delhi, India, investigated the accuracy of Masimo RRp® on pediatric patients with the Rad-G™ Pulse Oximeter by comparing it to clinician-determined values while performing routine assessment of children admitted to outpatient and emergency departments.1 RRp provides respiration rate determined from the photoplethysmograph used in pulse oximetry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200705005031/en/ Masimo Rad-G™ with RRp® (Photo: Business Wire) Noting the high incidence of childhood pneumonia in many parts of the world, the inclusion of oxygen saturation (SpO2) and respiratory rate measurement in pneumonia screening guidelines, and the scarcity of medical equipment and variability in medical training in many low-resource settings, Dr. Alwadhi and colleagues sought to determine whether a “multi
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom