Esperion Announces Oral Presentation on Genetic Validation of ATP Citrate Lyase Inhibition at the American College of Cardiol...
March 06 2017 - 8:30AM
Company to Host Webcast on Sunday, March 19, 2017
at 5:30 p.m. Eastern Time
Esperion Therapeutics, Inc. (NASDAQ:ESPR), the lipid management
company focused on developing and commercializing convenient,
complementary, cost-effective, once-daily, oral therapies for the
treatment of patients with elevated low density lipoprotein
cholesterol (LDL-C), today announced Brian A. Ference, M.D.,
M.Phil., M.Sc., F.A.C.C., Associate Professor of Medicine, Wayne
State University School of Medicine, will present results from
Mendelian randomization studies conducted to evaluate the effect of
lower LDL-C mediated by genetic variants in the ATP Citrate Lyase
(ACL) gene on the risk of cardiovascular events. The abstract,
“Genetic Target Validation for ATP-Citrate Lyase Inhibition” will
be presented in an oral presentation during the American College of
Cardiology (ACC) 66th Annual Scientific Session on Sunday, March
19, 2017 at 8:51 a.m. Eastern Time at the Walter E. Washington
Convention Center, Washington, DC in Room 147A. The abstract for
this presentation is available on the ACC website at:
http://bit.ly/2mvGXRx.
The importance of genetic validation of targets
for LDL-C lowering and cardiovascular disease risk reduction
through Mendelian randomization studies was highlighted at the
Proprotein Convertase Subtilisin Kexin 9 (PCSK9) inhibitor
Endocrine-Metabolism Advisory Committee meetings in June 2015.
Mendelian randomization studies have previously provided genetic
target validation for several LDL-receptor-mediated LDL-C lowering
therapies including 3-Hydroxy-3-Methyl-Glutaryl-Coezyme A (HMG-CoA)
reductase (the enzyme target of statins), Niemann-Pick C1 Like 1
(NPC1L1) (the enzyme target for ezetimibe) and PCSK9is.
In early 2016, Esperion partnered with Dr.
Ference to design and conduct Mendelian randomization studies to
determine the genetic validity of inhibition of ACL, the enzyme
target of bempedoic acid, for LDL-C lowering and the potential for
cardiovascular disease risk reduction. The Mendelian randomization
studies conducted on ACL by Dr. Ference, as with previous studies
of other LDL-C lowering therapies mediated by the LDL receptor,
identified a genetic score consisting of independently inherited
variants in the ACL gene, which mimic the effect of ACL inhibition.
Results from the studies demonstrated that these genetic variants
have the same effect on the risk for cardiovascular events per unit
change in LDL-C as variants that mimic the effects of statins,
PCSK9is and ezetimibe. Dr. Ference and colleagues concluded that an
ACL inhibitor such as bempedoic acid should reduce the risk of
cardiovascular events by the same amount as statins per unit
reduction in LDL-C.
Conference Call and Webcast Information
Esperion’s lipid management team will host a
conference call with Dr. Ference who will present his genetic
target validation research and results. The call can be accessed by
dialing (877) 831-3840 (domestic) or (253) 237-1184 (international)
five minutes prior to the start of the call and providing access
code 81690940. A live, listen-only webcast of the conference call
can be accessed on the investor relations section of the Esperion
website at investor.esperion.com, along with slides to accompany
this update. A webcast replay of the call will be available
approximately two hours after completion of the event and will be
archived on the Company's website for approximately 90 days.
Bempedoic Acid
With a targeted mechanism of action, bempedoic
acid is a first-in-class, orally available, once-daily ACL
inhibitor that reduces cholesterol biosynthesis and lowers elevated
levels of LDL-C by up-regulating the LDL receptor, but with reduced
potential for muscle-related side effects. Completed Phase 1 and 2
studies in more than 800 patients treated with bempedoic acid have
produced clinically relevant LDL-C lowering results of up to 30
percent as monotherapy, approximately 50 percent in combination
with ezetimibe, and an incremental 20+ percent when added to stable
statin therapy.
Esperion's Commitment to Patients with
Hypercholesterolemia
In the United States, 78 million people, or more
than 20 percent of the population, have elevated LDL-C; an
additional 73 million people in Europe and 30 million people in
Japan also live with elevated LDL-C. Esperion's mission as the
lipid management company is to provide patients and physicians with
convenient, complementary, cost-effective, once-daily, oral
therapies to significantly reduce elevated levels of LDL-C in
patients inadequately treated with current lipid-modifying
therapies. It is estimated that 40 million patients in the
U.S. are taking statins with approximately 5-20 percent of
these patients only able to tolerate less than the lowest approved
daily starting dose of their statin and considered "statin
intolerant”. Esperion-discovered and developed, bempedoic acid is a
targeted LDL-C lowering therapy in Phase 3 development. The Company
has two Phase 3 products in development: 1) bempedoic acid
(monotherapy) an oral, once-daily pill, and 2) an oral, once-daily
fixed dose combination pill of bempedoic acid and ezetimibe
(BA+EZ).
The Lipid Management Company
Esperion Therapeutics, Inc. is the lipid
management company passionately committed to developing and
commercializing convenient, complementary, cost-effective,
once-daily, oral therapies for the treatment of patients with
elevated LDL-C. Through scientific and clinical excellence, and a
deep understanding of cholesterol biology, the experienced lipid
management team at Esperion is committed to developing new LDL-C
lowering therapies that will make a substantial impact on reducing
global CVD; the leading cause of death around the world. Bempedoic
acid, the Company's lead product candidate, is a targeted therapy
that significantly reduces elevated LDL-C levels in patients with
hypercholesterolemia, including patients inadequately treated with
current lipid-modifying therapies. For more information, please
visit www.esperion.com and follow us on Twitter
at https://twitter.com/EsperionInc.
Forward-Looking Statements
This press release contains forward-looking
statements that are made pursuant to the safe harbor provisions of
the federal securities laws, including statements regarding the
therapeutic potential of, and clinical development plan for,
bempedoic acid, including the potential effect of bempedoic acid on
reducing risk of cardiovascular events. Any express or implied
statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements.
Forward-looking statements involve risks and uncertainties that
could cause Esperion's actual results to differ significantly from
those projected, including, without limitation, delays or failures
in the Company’s studies, including the risk that U.S. Food and
Drug Administration may require additional studies or data, that
Esperion may need to change the design of its Phase 3 program, that
positive results from a clinical study of bempedoic acid may not
necessarily be predictive of the results of future clinical
studies, particularly in different or larger patient populations,
that existing cash resources may be used more quickly than
anticipated, that Esperion’s global Phase 3 long-term safety and
tolerability program for bempedoic acid may not produce sufficient
safety or tolerability results or show meaningful change in LDL-C
or other key lipid measures of patients, or the risk that other
unanticipated developments or data could interfere with the scope
of development and commercialization of bempedoic acid, and the
risks detailed in Esperion's filings with the Securities and
Exchange Commission. You are cautioned not to place undue reliance
on the forward-looking statements, which speak only as of the date
of this release. Esperion disclaims any obligation or undertaking
to update or revise any forward-looking statements contained in
this press release, other than to the extent required by law.
Media Contact:
Elliot Fox
W2O Group
212.257.6724
efox@w2ogroup.com
Investor Contact:
Mindy Lowe
Esperion Therapeutics, Inc.
734.887.3903
mlowe@esperion.com
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