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.
About Lp(a)
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
About OCEAN(a)
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.
About Amgen
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.
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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.
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CONTACT: Amgen, Thousand Oaks
Michael Strapazon, 805-313-5553
(media)
Jessica Akopyan, 805-440-5721
(media)
Arvind Sood, 805-447-1060
(investors)
1. Kassner U, et
al. Atheroscler Suppl. 2015;18:263–7.
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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