Study Showed Significant, Sustained Reduction in Lipoprotein(a) During Treatment Period
Lipoprotein(a) Reduction was Consistent With Phase 1 Results
THOUSAND OAKS, Calif., May 31, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive topline data from the Phase 2 OCEAN(a)-DOSE clinical study, evaluating olpasiran (formerly AMG 890) in 281 adult patients with Lipoprotein(a), or Lp(a), levels over 150 nmol/L and evidence of atherosclerotic cardiovascular disease (ASCVD). Olpasiran is a small interfering RNA designed to lower the body's production of apolipoprotein(a), a key component of Lp(a) that has been associated with an increased risk of cardiovascular events.
In the double-blind placebo-controlled treatment period, olpasiran was administered up to 225 mg subcutaneously every 12 weeks to patients with a median baseline Lp(a) of approximately 260 nmol/L. These data demonstrated a significant reduction from baseline in Lp(a) of up to or greater than 90 percent at week 36 (primary endpoint) and week 48 (end of treatment period) for the majority of doses. No new safety concerns were identified during this treatment period.
"Lp(a) has remained an elusive target since it was first discovered almost 60 years ago because diet and exercise have minimal influence on Lp(a) levels as do currently available medicines, leaving patients with limited options," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are very enthusiastic about these results and look forward to advancing olpasiran as a potential treatment for patients with elevated Lp(a)."
Data from the Phase 2 study will be presented at a future medical congress and submitted for publication.
Lp(a) is genetically determined1,2 and reported to be an 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 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 .2
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 dosefinding Phase 2 study in 281 subjects 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 matched 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.
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 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's.
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2. Tsimikas S, et al. J Am Coll Cardiol. 2018;71):177-192.
3. van Buuren F, et al. Clin Res Cardiol Suppl. 2017;12:55–59.
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