Amarin Corporation plc (NASDAQ:AMRN), today announced support
for an investigator-initiated trial to study the effects of
icosapent ethyl (VASCEPA®) (IPE) on laboratory-confirmed viral
upper respiratory infection (URI) rates, clinical impact and
outcomes, especially with severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) infection which causes COVID-19, in
adults with established atherosclerotic cardiovascular disease
(ASCVD) who are at elevated risk of experiencing moderate to severe
COVID-19.1,2
The trial, dubbed PragMatic
randomIzed Trial of
Icosapent ethyl for
hiGh-cArdiovascular risk adults
in The Era of
COronaVIrus
Disease 2019 (MITIGATE
COVID-19), is sponsored by Kaiser Permanente Northern
California (KPNC), and is being led by Dr. Andrew P. Ambrosy,
Associate Program Director for Research (Fellowship), Department of
Cardiology, Kaiser Permanente San Francisco Medical Center, and Dr.
Alan S. Go, Regional Medical Director, Clinical Trials Program and
Associate Director, Cardiovascular and Metabolic Conditions
Research, Division of Research, Kaiser Permanente Northern
California.
MITIGATE COVID-19 will randomly assign 1500 U.S.
patients aged 50 years or older with established ASCVD and no prior
history of confirmed COVID-19 to receive 4 grams per day of
icosapent ethyl (VASCEPA) and follow these patients for a minimum
of 6 months. The co-primary study endpoints are the rate of
moderate to severe laboratory-confirmed viral URI, including
COVID-19 and influenza, prompting urgent care encounters, emergency
department visits, or hospitalization and the worst clinical status
due to a laboratory-confirmed viral URI based on an ordinal scale
taking hospitalization, death, supplemental oxygen, and other
clinical factors into account. A control group will consist of
15,000 adults meeting the same eligibility criteria who will be
passively followed through KPNC’s comprehensive and
state-of-the-art electronic health record system for outcome
ascertainment.
Current understanding of the biology of COVID-19
is that patients that have or are at high risk for developing ASCVD
are at higher risk of death and severe effects from infection, and
that the morbidity and mortality associated with COVID-19 are due
both to the direct toxicity of the virus as well as the body’s
robust inflammatory response leading to ‘cytokine
storm’.1,2,3,4 Based on data related to the mechanism of
action and effects of VASCEPA, it is hypothesized that VASCEPA may
play a potential beneficial role in preventing SARS-CoV-2 infection
and to potentially reduce clinical severity in patients infected by
the virus.4,5,6
The clinical effects of VASCEPA are
multi-factorial. Multiple mechanisms of action associated with
VASCEPA based on clinical and mechanistic studies support the
rationale to test its effects in patients with or at risk for
COVID-19 disease. Some of these postulated mechanisms include the
following:
- Potential antiviral/antimicrobial effects7,8
- Fibrosis and cardiac damage mitigation in animal
models9,10
- Anti-inflammatory effects (acute) in pulmonary/lung
tissue11,12
“Most prior clinical trials for COVID-19 have
focused on treating patients hospitalized for moderate or severe
COVID-19 with experimental agents,” according to Dr. Ambrosy.
“MITIGATE COVID-19 is novel in that we will study
the effects of pre-treatment with IPE, an FDA-approved therapy for
primary and secondary prevention with putative anti-inflammatory as
well as antiviral properties, in high-risk outpatients with ASCVD
on subsequent risk of viral URI-related morbidity and
mortality.”
Dr. Go further stated, “In my 20+ years as a
health services researcher and clinical trialist, this is the first
time that a large-scale study will be undertaken using a completely
virtual model including patient recruitment and consent, follow-up
visits, and outcome ascertainment within an ethnically-diverse,
community-based population. Kaiser Permanente Northern California
has been at the forefront of telehealth for delivering high-quality
clinical care, especially during the current pandemic, and we are
pleased to be able to adapt this innovative approach for safely and
efficiently testing a potential intervention.”
For more information about Amarin’s COVID-19
research, please visit the COVID-19 Related Materials section on
Amarin’s publications page at
https://investor.amarincorp.com/publications.
About Amarin
Amarin Corporation plc is a rapidly growing,
innovative pharmaceutical company focused on developing and
commercializing therapeutics to cost-effectively improve
cardiovascular health. Amarin’s lead product, VASCEPA (icosapent
ethyl), is available by prescription in the United States, Canada,
Lebanon and the United Arab Emirates. Amarin, together with its
commercial partners in select geographies, is pursuing additional
regulatory approvals for VASCEPA in China, Europe and the Middle
East. For more information about Amarin, visit
www.amarincorp.com.
About Cardiovascular Risk
The number of deaths in the United States
attributed to cardiovascular disease continues to rise. There are
605,000 new and 200,000 recurrent heart attacks per year
(approximately 1 every 40 seconds), in the United States. Stroke
rates are 795,000 per year (approximately 1 every 40 seconds),
accounting for 1 of every 19 U.S. deaths. Cardiovascular disease
results in 859,000 deaths per year in the United States.13 In
aggregate, this is more than 2.4 million major adverse
cardiovascular events per year from cardiovascular disease or, on
average, one every 13 seconds in the United States alone.
Controlling bad cholesterol, also known as
LDL-C, is one way to reduce a patient’s risk for cardiovascular
events, such as heart attack, stroke or death. However, even with
the achievement of target LDL-C levels, millions of patients still
have significant and persistent risk of cardiovascular events,
especially those patients with elevated triglycerides. Statin
therapy has been shown to control LDL-C, thereby reducing the risk
of cardiovascular events by 25-35%.14 Significant cardiovascular
risk remains after statin therapy. People with elevated
triglycerides have 35% more cardiovascular events compared to
people with normal (in range) triglycerides taking
statins.15,16,17
About REDUCE-IT
REDUCE-IT was a global cardiovascular outcomes
study designed to evaluate the effect of VASCEPA in adult patients
with LDL-C controlled to between 41-100 mg/dL (median baseline 75
mg/dL) by statin therapy and various cardiovascular risk factors
including persistent elevated triglycerides between 135-499 mg/dL
(median baseline 216 mg/dL) and either established cardiovascular
disease (secondary prevention cohort) or diabetes mellitus and at
least one other cardiovascular risk factor (primary prevention
cohort).
REDUCE-IT, conducted over seven years and
completed in 2018, followed 8,179 patients at over 400 clinical
sites in 11 countries with the largest number of sites located
within the United States. REDUCE-IT was conducted based on a
special protocol assessment agreement with FDA. The design of the
REDUCE-IT study was published in March 2017 in Clinical
Cardiology.18 The primary results of REDUCE-IT were published in
The New England Journal of Medicine in November 2018.19 The total
events results of REDUCE-IT were published in the Journal of the
American College of Cardiology in March 2019.20 These and other
publications can be found in the R&D section on the company’s
website at www.amarincorp.com.
About VASCEPA®
(icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the FDA comprised
solely of the active ingredient, icosapent ethyl (IPE), a unique
form of eicosapentaenoic acid. VASCEPA was initially launched in
the United States in 2013 based on the drug’s initial FDA-approved
indication for use as an adjunct therapy to diet to reduce
triglyceride levels in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia. Since launch, VASCEPA has been prescribed
over eight million times. VASCEPA is covered by most major medical
insurance plans. The new, cardiovascular risk indication for
VASCEPA was approved by the FDA in December 2019.
Indications and Limitation of Use
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce
the risk of myocardial infarction, stroke, coronary
revascularization and unstable angina requiring hospitalization in
adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL)
and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for
cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients
with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for
pancreatitis in patients with severe hypertriglyceridemia has not
been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of
its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of
atrial fibrillation or atrial flutter requiring hospitalization in
a double-blind, placebo-controlled trial. The incidence of atrial
fibrillation was greater in patients with a previous history of
atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or
shellfish are at an increased risk of an allergic reaction to
VASCEPA. Patients with such allergies should discontinue VASCEPA if
any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of
bleeding in a double-blind, placebo-controlled trial. The incidence
of bleeding was greater in patients receiving concomitant
antithrombotic medications, such as aspirin, clopidogrel or
warfarin.
- Common adverse reactions in the cardiovascular outcomes trial
(incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal
pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs
4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials
(incidence >1% more frequent than placebo): arthralgia (2% vs
1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the
FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants
and/or anti-platelet agents should be monitored for bleeding.
Key clinical effects of VASCEPA on major adverse
cardiovascular events are included in the Clinical Studies section
of the prescribing information for VASCEPA, as set forth below:
Effect of VASCEPA on Time to First
Occurrence of Cardiovascular Events in Patients with Elevated
Triglyceride levels and Other Risk Factors for Cardiovascular
Disease in REDUCE-IT
|
VASCEPA |
Placebo |
VASCEPA vs Placebo |
N = 4089 n (%) |
Incidence Rate (per 100 patient years) |
N = 4090 n (%) |
Incidence Rate (per 100 patient years) |
Hazard Ratio (95% CI) |
Primary composite endpoint |
Cardiovascular death, myocardial infarction, stroke, coronary
revascularization, hospitalization for unstable angina (5-point
MACE) |
705 (17.2) |
4.3 |
901 (22.0) |
5.7 |
0.75 (0.68, 0.83) |
Key secondary composite endpoint |
Cardiovascular death, myocardial infarction, stroke (3-point
MACE) |
459 (11.2) |
2.7 |
606 (14.8) |
3.7 |
0.74 (0.65, 0.83) |
Other secondary endpoints |
Fatal or non-fatal myocardial infarction |
250 (6.1) |
1.5 |
355 (8.7) |
2.1 |
0.69 (0.58, 0.81) |
Emergent or urgent coronary revascularization |
216 (5.3) |
1.3 |
321 (7.8) |
1.9 |
0.65 (0.55, 0.78) |
Cardiovascular death [1] |
174 (4.3) |
1.0 |
213 (5.2) |
1.2 |
0.80 (0.66, 0.98) |
Hospitalization for unstable angina [2] |
108 (2.6) |
0.6 |
157 (3.8) |
0.9 |
0.68 (0.53, 0.87) |
Fatal or non-fatal stroke |
98 (2.4) |
0.6 |
134 (3.3) |
0.8 |
0.72 (0.55, 0.93) |
[1] Includes adjudicated cardiovascular deaths and deaths of
undetermined causality. [2] Determined to be caused by myocardial
ischemia by invasive/non-invasive testing and requiring emergent
hospitalization. |
FULL VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements regarding the potential for
benefit from the study of VASCEPA in the treatment of patients with
COVID-19. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. Among
the factors that could cause actual results to differ materially
from those described or projected herein include the following:
uncertainties associated generally with research and development
and clinical trials. A further list and description of these risks,
uncertainties and other risks associated with an investment in
Amarin can be found in Amarin's filings with the U.S. Securities
and Exchange Commission, including its most recent quarterly report
on Form 10-Q. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Amarin undertakes no obligation
to update or revise the information contained in this press
release, whether as a result of new information, future events or
circumstances or otherwise. Amarin’s forward-looking statements do
not reflect the potential impact of significant transactions the
company may enter into, such as mergers, acquisitions,
dispositions, joint ventures or any material agreements that Amarin
may enter into, amend or terminate.
Availability of Other Information About
Amarin
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and investor FAQs, Securities and Exchange Commission
filings, press releases, public conference calls and webcasts. The
information that Amarin posts on these channels and websites could
be deemed to be material information. As a result, Amarin
encourages investors, the media, and others interested in Amarin to
review the information that is posted on these channels, including
the investor relations website, on a regular basis. This list of
channels may be updated from time to time on Amarin’s investor
relations website and may include social media channels. The
contents of Amarin’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
Amarin Contact Information
Investor Inquiries:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908)
719-1315IR@amarincorp.com (investor inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992lstern@soleburytrout.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028PR@amarincorp.com (media inquiries)
References
______________________________
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2 Zhou F, Yu T, Du R, et al. Clinical course and risk factors
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