THOUSAND OAKS, Calif., Aug. 26, 2023
Amgen is Changing the Cardiovascular Disease Treatment Landscape With New Research on Innovative Lipid Management
New Olpasiran Phase 2 Data Demonstrates Continued Reduction of Lp(a) Nearly a Year After the Last Dose
Amgen Convenes First LDL Awareness to Action Implementation Consortium
THOUSAND OAKS, Calif., Aug. 26, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced data from the final analysis of the Phase 2 OCEAN(a)-DOSE study of olpasiran, a small interfering RNA (siRNA) during the Late-Breaking Science Session at the European Society of Cardiology (ESC) Annual Meeting being held in Amsterdam. In the off-treatment extension period, olpasiran showed a lasting effect on Lp(a) reduction nearly a year after the last dose.
Results from the OCEAN(a)-DOSE Phase 2 study announced in November of 2022 showed that doses of olpasiran ≥75 mg Q12W reduced patients' Lp(a) by >95% at week 36. The results from the off-treatment extension period show that patients previously dosed with ≥75 mg of olpasiran sustained a ~40-50% placebo-adjusted percent reduction in Lp(a) nearly a year after the last dose. No new safety concerns were identified during the off-treatment extension period.
"We are dedicated to reducing LDL cholesterol levels in people globally and continuing to pioneer ways to address the greatest risk factors in cardiovascular disease, including Lp(a). Worldwide, millions of people are at an increased risk of cardiovascular events due to elevated Lp(a) levels. Unfortunately, there are no approved medicines," said Paul Burton, senior vice president and chief medical officer at Amgen. "Data from the off-treatment extension period provide additional evidence of olpasiran's lasting effect in reducing Lp(a) levels. We are quickly advancing the Phase 3 cardiovascular outcome trial."
Additionally, this study was the first to explore the effects of olpasiran on a key biomarker strongly associated with atherosclerosis, pro-atherogenic OxPL-apoB [Oxidized Phospholipids (Ox-PL) on apoB-100 (apoB)]. During the treatment period, olpasiran showed a dose-dependent reduction in pro-atherogenic OxPL-apoB.
"Additional results from the OCEAN(a)-DOSE study continue to be encouraging, as they tell us olpasiran not only robustly reduces Lp(a) levels, but that it has a long-lasting effect on this important risk factor for ASCVD," said Michelle L. O'Donoghue, MD, MPH, associate professor, Harvard Medical School, Cardiovascular Medicine and lead investigator of the OCEAN(a)-DOSE study. "Additionally, we were able to show that olpasiran reduced OxPL-apoB, further adding to the potential of RNA interference with olpasiran as a promising treatment approach to reducing elevated Lp(a)."
LDL Awareness to Action Implementation Consortium
Amgen is committed to working with stakeholders to achieve the goal of reducing cardiovascular disease globally and, this year at ESC, convened a new LDL Awareness to Action Implementation Consortium (LATAIC). LATAIC is focused on improving LDL-C testing and evidence-based treatment through identification of opportunities to accelerate efficiency and impact of the translation of evidence-based research into clinical practice. The consortium is comprised of leading CV institutions, including Duke, Harvard's BAIM Institute, Johns Hopkins, Geisinger, University of Colorado, St. Luke's, Brigham and Women's Hospital, Providence, Yale and UT Southwestern.
"I am proud to be working alongside Amgen and other cross disciplinary leaders in the cardiovascular space to increase LDL-C testing and implementation of evidence-based treatment, in order to tackle the urgent public health crisis of cardiovascular disease," said C. Michael Gibson, M.D., chief executive officer at the non-profit BAIM Institute of Clinical Research, and professor of medicine, Harvard. "We hope to enable scalable action to address unmet LDL needs, drive efficiency, and improve quality of care for patients by expanding LATAIC to include other CVD industry stakeholders."
For more information about the ESC abstracts, see below.
- RNA inhibition of Lp(a) with Olpasiran: Effects on Oxidized Phospholipids and Primary Results of the OCEAN(a)-DOSE Extension Program on Long-Term Efficacy and Safety
Late-breaker, Saturday, Aug. 26, 4:45-5:00 pm CEST
- Cardiovascular Outcomes in Patients with Coronary Artery Disease and Elevated Lipoprotein(a): Implications for the OCEAN(a)-Outcomes Trial Population.
Oral Presentation, Sunday, Aug. 27, 10:55-11:05 am CEST
- Characteristics of patients initiating PCSK9i mAb following myocardial infarction and comparability of treatment groups in the Netherlands.
Moderated poster, Monday, Aug. 28, 2:15-3:00 pm CEST
- Improving risk stratification of recurrent myocardial infarction in a large real-world dataset using machine learning.
Moderated poster, Saturday, Aug. 26, 11:15-12:00 pm CEST
Investigator-Sponsored Studies (ISS)
- Randomised trial of cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients.
Late-breaker, Monday, Aug. 28, 11:30-11:45 am CEST
- Effect of evolocumab on platelet function in patients with acute coronary syndromes: An analysis of the randomized, double-blind, placebo-controlled EVOPACS Trial.
Moderated poster, Monday, Aug. 28, 5:15-6:00 pm CEST
- PCSK9 inhibition with evolocumab decreases myocardial inflammation in individuals with acute coronary syndrome [EVACS data].
Oral presentation, Saturday, Aug. 26, 2:00-2:10 pm CEST
- Lipoprotein(a) and the risk of Major Adverse Limb Events in Patients with Stable Atherosclerotic Vascular Disease [FOURIER/no evo data].
Moderated poster, Saturday, Aug. 26, 11:15-12:00 pm CEST
Lp(a) is genetically determined1-5 and a presumed independent risk factor for cardiovascular disease (CVD). Although an agreed-upon threshold for elevated Lp(a) is not firmly established, approximately 20% of adults have Lp(a) >125 nmol/L (or approximately 50 mg/dL).3,4 Evidence has emerged from pathophysiological, epidemiologic, and genetic studies on the potential role of elevated Lp(a) in contributing to myocardial infarction, stroke, and peripheral arterial disease.5
The OCEAN(a) (Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction) clinical program for Amgen's investigational olpasiran is designed to treat patients with atherosclerotic cardiovascular disease (ASCVD) and elevated Lp(a) levels to reduce the risk of cardiovascular events. The OCEAN(a)-DOSE trial is a multicenter, randomized, double-blind, placebo-controlled dose-finding Phase 2 study in 281 patients with ASCVD and Lp(a) >150 nmol/L. Patients were randomly assigned to one of four active subcutaneous doses of olpasiran (10 mg Q12 weeks, 75 mg Q12 weeks, 225 mg Q12 weeks or 225 mg Q24 weeks) or placebo. The primary endpoint is percent change from baseline in Lp(a) at 36 weeks. A secondary endpoint is percent change from baseline in Lp(a) at 48 weeks. For the off-treatment extension period, patients were followed for a minimum of 24 weeks. A biomarker discovery analysis was performed on the percent change from baseline in OxPL-apoB [Oxidized Phospholipids (Ox-PL) on apoB-100 (apoB)] at weeks 36 and 48.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek and one of "America's Climate Leaders" by USA Today.
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1 Wilson DP, et al. Clin Lipidol. 2019;13(3):374-92.
2 Reyes-Soffer G, et al. Arterioscler Thromb Vasc Biol. 2022;42(1):e48-e60.
3 Kronenberg F, et al. Eur Heart J. 2022;43(39):3925-3946.
4 Tsimikas S, Stroes ESG. Atherosclerosis. 2020;300:1-9.
5 Tsimikas S, et al. J Am Coll Cardiol. 2018;71(2):177–192.
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