— Study Met Primary Endpoint with 30%
Additional LDL-C Lowering — — hsCRP Reduction of 34% — —
Observed to be Safe and Well-Tolerated in This Study — —
Conference Call and Webcast on Tuesday, March 27, 2018, at 8:30
a.m. Eastern Daylight Time —
Esperion (NASDAQ:ESPR), the Lipid Management Company focused on
developing and commercializing complementary, convenient,
cost-effective, once-daily, oral therapies for the treatment of
patients with elevated low density lipoprotein cholesterol (LDL-C),
today announced positive top-line results from the Phase 2 clinical
study (1002-039) that evaluated the LDL-C lowering efficacy and
safety of bempedoic acid 180 mg added-on to stable background
therapy of a proprotein convertase subtilisin/kexin type 9 (PCSK9)
inhibitor in 58 patients with hypercholesterolemia.
The eight-week study met its primary endpoint with additional
LDL-C lowering totaling 30 percent (p<0.001). The LDL-C lowering
for the bempedoic acid group was 27 percent from baseline, as
compared to an increase of three percent for the placebo group.
Patients treated with bempedoic acid also achieved a significantly
greater reduction of 34 percent in high-sensitivity C-reactive
protein (hsCRP), an important marker of the underlying inflammation
associated with cardiovascular disease, compared to the placebo
group which had a reduction of two percent (p<0.029).
A chart accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/34d52ec4-3105-476e-8eca-d44fc6a0aa20
“Bempedoic acid has previously demonstrated the ability to
complement currently available standard-of-care oral LDL-C lowering
therapies, and the results of this Phase 2 study show that
bempedoic acid can also be safely and effectively used in patients
who require additional LDL-C lowering despite taking an injectable
PCSK9 inhibitor,” said Tim M. Mayleben, president and chief
executive officer of Esperion. “These Phase 2 results provide
consistent evidence and further support that bempedoic acid is
poised to become the broadly accessible, complementary, once-daily,
oral LDL-C lowering therapy that is appealing to patients,
physicians and payers.”
In this study, bempedoic acid was observed to be safe and
well-tolerated. There were essentially no differences in the
occurrence of adverse events (AEs) between the bempedoic acid and
placebo groups, serious adverse events or muscle-related AEs. There
were no discontinuations due to AEs or muscle-related AEs. No
patients in either group had elevations in liver function tests
(ALT/AST) of greater than three times the upper limit of normal,
repeated and confirmed. The cumulative number of patients now
treated with bempedoic acid in completed Phase 2 and Phase 3
clinical trials totals 947. Of these, six patients (0.63 percent)
had elevations in liver function tests. This rate of elevations in
liver function tests is consistent with the rate observed in
previous clinical trials and with all other previously approved
oral LDL-C-lowering therapies, including statins and ezetimibe.
A chart accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/ae4d47e8-302e-4af3-8fab-0d3f36c351d0
Design of Phase 2 Study 1002-039
This eight-week Phase 2, randomized, double-blind,
placebo-controlled, multicenter study evaluated the efficacy and
safety of bempedoic acid 180 mg/day in patients with
hypercholesterolemia at screening (LDL-C ≥ 160 mg/dL) who then
received 12 weeks of background injectable evolocumab 420 mg
administered every four weeks prior to randomization. A total of 59
patients from 21 sites in the U.S. and Canada were then randomized
1:1 to receive bempedoic acid or placebo added-on to evolocumab.
The primary efficacy objective was to assess the eight-week LDL-C
lowering efficacy of bempedoic acid versus placebo in patients on a
PCSK9 inhibitor. Secondary objectives included evaluating the
safety and tolerability of bempedoic acid versus placebo and its
effects on other risk markers, including hsCRP.
Conference Call and Webcast Information
Esperion will host a conference call and webcast
today, Tuesday, March 27, 2018, at 8:30 a.m. Eastern Time to
discuss these Phase 2 study results. The call can be accessed by
dialing (877) 312-7508 (domestic) or (253) 237-1184 (international)
five minutes prior to the start of the call and providing access
code 8056235. A live audio webcast can be accessed on the investors
and media section of the Esperion website at investor.esperion.com.
Access to the webcast replay will be available approximately two
hours after completion of the call and will be archived on the
Company's website for approximately 90 days.
About Esperion’s Global Pivotal Phase 3 LDL-C
Lowering Program
Esperion initiated its global, pivotal, Phase 3
clinical development program in January 2016 to evaluate the
safety, tolerability and consistent, complementary LDL-C-lowering
efficacy of bempedoic acid and the bempedoic acid / ezetimibe
combination pill in patients with atherosclerotic cardiovascular
disease (ASCVD), or who are at a high risk for ASCVD, with
hypercholesterolemia who continue to have elevated levels of LDL-C
despite the use of maximally-tolerated statins and ezetimibe,
leaving them at high risk for cardiovascular events. The program
includes five studies in approximately 4,000 patients, four for
bempedoic acid and one for the bempedoic acid / ezetimibe
combination pill.
- Two pivotal studies evaluating bempedoic acid (Studies 1 &
2) in 3,000 patients with ASCVD on maximally-tolerated statin
therapy, with top-line results expected in early May and September
2018, respectively;
- Two pivotal studies evaluating bempedoic acid (Studies 3 &
4) in 600 patients with ASCVD, or at a high risk for ASCVD,
considered statin intolerant. Top-line results from Study 4 were
reported in March 2018, and top-line results from Study 3 are
expected in May 2018;
- One pivotal study evaluating the bempedoic acid / ezetimibe
combination pill (053 Study) in 350 patients with ASCVD, or at high
risk for ASCVD, on maximally-tolerated statin therapy, with
top-line results expected in August 2018.
Esperion plans to submit New Drug Applications
(NDAs) to the U.S. Food and Drug Administration (FDA) for bempedoic
acid and the bempedoic acid / ezetimibe combination pill for
LDL-C-lowering indications by the first quarter of 2019.
Additionally, Esperion plans to submit Marketing Authorization
Applications (MAAs) to the European Medicines Agency (EMA) by the
second quarter of 2019.
About Bempedoic Acid
With a targeted mechanism of action, bempedoic
acid is a first-in-class, complementary, orally available,
once-daily ATP Citrate Lyase (ACL) inhibitor that reduces
cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL
receptor. Similar to statins, bempedoic acid also reduces hsCRP, a
key marker of inflammation associated with cardiovascular disease.
Completed Phase 1, Phase 2 and Phase 3 studies conducted in
approximately 1,600 patients, and close to 1,000 patients treated
with bempedoic acid, have produced 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.
The effect of bempedoic acid on cardiovascular
morbidity and mortality has not yet been determined.
Esperion's Commitment to Patients with
Hypercholesterolemia
High levels of LDL-C can lead to a build-up of
fat and cholesterol in and on artery walls (known as
atherosclerosis), potentially leading to cardiovascular events,
including heart attack or stroke. In the U.S., 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. There are approximately 13
million people in the U.S. with atherosclerotic cardiovascular
disease (ASCVD) who live with elevated levels of LDL-C despite
taking maximally-tolerated lipid-modifying therapy – including
individuals considered statin intolerant – leaving them at high
risk for cardiovascular events. The vast majority of these
patients, 9.5 million, require less than 30 percent additional
LDL-C lowering to achieve treatment goals.
Esperion's mission as the Lipid Management Company is to deliver
once-daily, oral therapies that complement existing oral drugs to
provide the additional LDL-C lowering that these patients need.
The Lipid Management Company
Esperion 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 cardiovascular disease; the leading cause of death around
the world. Bempedoic acid and the company's lead product candidate,
the bempedoic acid / ezetimibe combination pill, are targeted
therapies that have been shown to significantly lower 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
regulatory approval pathway for the bempedoic acid / ezetimibe
combination pill and bempedoic acid and the therapeutic potential
of, clinical development plan for, the bempedoic acid / ezetimibe
combination pill and bempedoic acid, including Esperion's timing,
designs, plans and announcement of results from studies in the
global pivotal Phase 3 clinical development program for bempedoic
acid and the bempedoic acid / ezetimibe combination pill,
Esperion’s timing and plans for submission of NDAs to the FDA and
MAAs to the EMA and Esperion’s expectations for the market for
therapies to lower LDL-C, including the market adoption of
bempedoic acid, if approved. 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 Esperion’s studies, including the risk that Esperion may need to
change the design of its Phase 3 program, that existing cash
resources may be used more quickly than anticipated, that the
pivotal Phase 3 program 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, approval and commercialization of the bempedoic
acid / ezetimibe combination pill and bempedoic acid, and the other
risks detailed in Esperion's filings with the Securities and
Exchange Commission. 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: Audrey Gross W2O
Group212.301.7214 agross@w2ogroup.com
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