Pfizer research program only one to assess role
of PCSK9 inhibitors in reducing risk of cardiovascular events in
high-risk patients without history of cardiovascular events
Pfizer Inc. today announced patient enrollment completion in the
global SPIRE-2 cardiovascular outcome trial for its investigational
agent bococizumab. SPIRE-2 is evaluating the efficacy and safety of
bococizumab compared to placebo in reducing the risk of major
cardiovascular events among approximately 10,600 patients at high
risk for cardiovascular disease - including those without a prior
history of cardiovascular events – who are on highly-effective
statins or with documented statin intolerance.
The SPIRE-2 study is one of two cardiovascular outcome trials
that are part of the SPIRE Phase 3 global clinical development
program that will evaluate the investigational Proprotein
Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i) bococizumab
in approximately 32,000 patients with high cholesterol. Many
factors impact the duration of cardiovascular outcome studies,
including that they are time-to-event trials, which can make it
difficult to predict when the studies will accrue the required
number of events. Based on current estimates, the SPIRE-2 study is
expected to complete in the second half of 2017.
“Pfizer has been a leader in redefining the management of
cardiovascular risk for decades, and we are applying our deep
understanding of cardiovascular disease to the SPIRE Phase 3
program,” said James M. Rusnak, MD, PhD, Therapeutic Area Clinical
Head for Cardiovascular and Metabolic Disease, Global Product
Development. ”We have designed our cardiovascular outcome trials
differently from other PCSK9i outcome trials to include both
primary and secondary prevention patients at high risk for a
cardiovascular event.”
The SPIRE program for bococizumab is the only PCSK9i research
program explicitly assessing cardiovascular outcomes in a broad
range of high-risk primary and secondary prevention patients -
including those with diabetes, chronic kidney disease, peripheral
vascular disease, familial hypercholesterolemia, and history of
heart attack or stroke or cardiovascular revascularization
procedures – with low-density lipoprotein cholesterol
(LDL-C)≥100mg/dL, despite the use of highly effective statins or
with documented statin intolerance.
In the multicenter, double-blind SPIRE-2 trial, patients with
LDL-C ≥100 mg/dL or non-HDL-C ≥130 mg/dL were randomized to receive
either bococizumab 150mg or placebo every two weeks in addition to
highly-effective statins unless patients had documented statin
intolerance. The primary endpoint in SPIRE-2 is time to first
occurrence of a major cardiovascular event, which includes
cardiovascular-related death, non-fatal heart attack, non-fatal
stroke, and hospitalization for unstable angina needing urgent
revascularization (i.e., heart bypass, angioplasty). The study is
evaluating other endpoints as well, including the safety and
tolerability of bococizumab.
About cardiovascular disease
Cardiovascular disease remains the leading cause of death
worldwide.1 High LDL-C is a known modifiable risk factor for
cardiovascular events such as heart attack and stroke.2,3,4,5
Despite the availability of highly effective lipid-lowering
therapies, such as statins, many patients remain at high risk for
cardiovascular events.6,7,8,9 Of note, in the U.S., more than 70%
of heart attacks occur in patients without a previous
cardiovascular event.10
About SPIRE
Pfizer has created SPIRE (Studies of PCSK9
Inhibition and the Reduction of vascular
Events), an extensive research program to study bococizumab,
its investigational PCSK9i. The SPIRE Phase 3 global clinical
development program will include approximately 32,000 patients and
consists of six lipid-lowering studies (SPIRE-SI, SPIRE-AI,
SPIRE-HR, SPIRE-FH, SPIRE-LL and SPIRE-LDL) as well as two
cardiovascular outcome studies (SPIRE-1 and SPIRE-2).
The lipid-lowering studies are evaluating the LDL-C lowering
efficacy, safety, and tolerability of bococizumab in adult patients
at risk of cardiovascular events, while the two cardiovascular
outcome studies are investigating the ability of bococizumab to
reduce the risk of cardiovascular events in a broad range of
high-risk primary and secondary prevention patients, including
those with diabetes, chronic kidney disease, peripheral vascular
disease or familial hypercholesterolemia, in addition to those with
previous cardiovascular events such as heart attack, stroke, or
cardiovascular revascularization procedures.
Pfizer’s cardiovascular outcome program for bococizumab is the
only PCSK9i research program explicitly assessing cardiovascular
outcomes in high-risk primary and secondary prevention patients
with an LDL-C ≥100mg/dL, despite the use of highly-effective
statins or with documented partial or complete statin
intolerance.
About bococizumab
Bococizumab is an investigational compound and has not received
regulatory approval in any country.
Bococizumab is a PCSK9i being studied for its potential to lower
LDL-C and improve cardiovascular outcomes in a broad range of
high-risk primary and secondary prevention patients. It works by
blocking the function of the PCSK9 protein, which interferes with
the clearance of LDL-C, a leading known risk factor for heart
disease.
More information about the bococizumab Phase 3 program can be
found at www.clinicaltrials.gov.
About Pfizer Inc.: Working together for a healthier
world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of healthcare
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. For more information, please visit us at
www.pfizer.com. In addition, to learn more, follow us on Twitter
@Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this
release is as of April 26, 2016. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s
product candidate, bococizumab, including its potential benefits,
that involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Risks and uncertainties include, among other
things, the uncertainties inherent in research and development,
including the ability to meet anticipated trial commencement and
completion dates and regulatory submission dates, as well as the
possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing
clinical data; whether and when any applications for bococizumab
may be filed with regulatory authorities in any jurisdictions;
whether and when regulatory authorities in any jurisdictions may
approve such applications, which will depend on the assessment by
such regulatory authorities of the benefit-risk profile suggested
by the totality of the efficacy and safety information submitted;
decisions by regulatory authorities regarding labeling and other
matters that could affect the availability or commercial potential
of bococizumab; and competitive developments. The competitive
landscape for lipid-lowering therapies, including PCSK9 inhibitors,
continues to evolve. The success of our bococizumab program is
dependent on developments in that space.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2015 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
References:
1 World Health Organization. Cardiovascular diseases (CVDs) Fact
sheet N°317. Updated January 2015.
http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed April
8, 2016.2 Prospective Studies Collaboration. Lancet. 2007 Dec 1;
370(9602): 1829-1839.3 Iso H, Jacobs DR Jr, Wentworth D, et al. N
Engl J Med. 1989 Apr 6; 320(14): 904-910.4 NCEP Adult Treatment
Panel III. Circulation. 2002 Dec 17; 106(25): 3143-3421.5 Grundy
SM, Cleeman JI, Merz CN, et al. Circulation. 2004 Jul 13; 110(2):
227-239.6 Cholesterol Treatment Trialists’ (CTT) Collaborators.
Lancet. 2005 Oct 8; 366(9493): 1267-1278.7 Cholesterol Treatment
Trialists’ (CTT) Collaboration. Lancet. 2010 Nov 13; 376(9753):
1670-1681.8 Fruchart JC, Sacks FM, Hermans MP, et al. Diabetes Vasc
Dis Res. 2008 Nov; 5(4): 319-335.9 Sampson UK, Fazio S, Linton MF.
Curr Atheroscler Rep. 2012 Feb; 14(1): 1-10.10 Mozaffarian,
Dariush, et al. Circulation. 2015 Jan 27;131(4):e29-322.
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version on businesswire.com: http://www.businesswire.com/news/home/20160426005995/en/
Pfizer Inc.Media RelationsSteven Danehy,
212-733-1538Steven.Danehy@pfizer.comorInvestor RelationsRyan Crowe,
212-733-8160Ryan.Crowe@pfizer.com
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