Amarin Corporation plc (NASDAQ:AMRN) today announced the
presentation of clinical results from the CardioLink-9 Trial, the
first results of a study of VASCEPA® (icosapent ethyl) in COVID-19
infected outpatients. The presentation, “First Human Trial of a
Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary
Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial”, was
made virtually as a Late Breaker at the National Lipid Association
(NLA) Scientific Sessions 2020, and was presented on behalf of all
authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s
Hospital, Harvard Medical School, Boston, MA.
“In the current environment, most COVID-19
positive patients remain outside of the clinical setting, following
the advice of their doctor to stay home and quarantine unless
absolutely necessary to enter the hospital,” commented Subodh
Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at
University of Toronto and co-principal investigator of COVID-19
CardioLink-9 and the encouraging results of this pilot study. “The
large and significant improvement in patient-reported symptoms may
provide a safe, well-tolerated, and relatively inexpensive option
to impact upon COVID-19-related morbidity. The reduction in markers
of inflammation with icosapent ethyl is also important given what
we know about the pathobiology of COVID-19.”
The VASCEPA COVID-19 CardioLink-9 Trial was a
randomized, open-label trial enrolling 100 SARS-CoV-2 positive and
symptomatic outpatients displaying at least one of the following:
fever, cough, sore throat, shortness of breath, myalgia. Patients
in the VASCEPA arm received a loading dose of 8 g/day for 3 days
followed by 4 g/day for 11 days on top of usual care. Patients
randomized to the non-active arm received usual care. Baseline
characteristics were comparable between groups.
The primary biomarker endpoint of the study was
within-group changes in high-sensitivity C-reactive protein
(hsCRP), a measure of inflammation. Within-group changes in D-dimer
were also examined. VASCEPA administration resulted in a 25%
reduction in hsCRP (p=0.011) as well as a reduction in D-dimer
(p=0.048).
In addition to these biomarker changes,
assessment was made of COVID-19 symptom changes from baseline to 14
days in the influenza patient-reported outcome (FLU-PRO) score, a
validated patient-reported outcome measure designed to evaluate the
presence, severity and duration of flu symptoms in clinical trials.
VASCEPA administration resulted in a significant 52% reduction of
the total FLU-PRO prevalence score as compared to a 24% reduction
in the usual care group (p=0.003 between groups), with reductions
across individual score domains, including a significantly larger
reduction compared to usual care in the body/systemic domain (54%
vs. 26%; p=0.003). Significant reductions in the FLU-PRO symptom
score compared to usual care were also observed in the total
symptom score (p=0.003), as well as in the body/systemic (p=0.0007)
and chest/respiratory (p=0.01) domains.
VASCEPA CardioLink-9 Study is an
investigator-initiated study supported by Amarin and by HLS
Therapeutics, Inc. The principal investigators of the study were
Subodh Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at
University of Toronto and Deepak L. Bhatt, M.D., M.P.H., Executive
Director of Interventional Cardiovascular Programs at Brigham and
Women’s Hospital and Professor of Medicine at Harvard Medical
School.
Limitations of this study include the modest
sample size, the unblinded nature of this randomized trial, and
that the trial was not powered for clinical events. These results
have not yet been published or reviewed by regulatory authorities.
Additional study is needed.
This randomized trial represents the first human
experience with an 8 g/day loading dose of icosapent ethyl and has
suggested short-term safety and tolerability in a modest sample
size. Regarding COVID-19, this study provides the first evidence of
potential early anti-inflammatory effect of icosapent ethyl in
symptomatic, COVID-19 positive outpatients.
Amarin added that the VASCEPA COVID-19
CardioLink-9 trial is the first in a series of ongoing
investigator-sponsored studies into the potential role of VASCEPA
therapy in COVID-19 settings. Other ongoing trials include
PREPARE-IT: Prevention of COVID19 With EPA in Healthcare Providers
at Risk - Intervention Trial sponsored by Estudios Clínicos Latino
América, and A Pragmatic Randomized Trial of Icosapent Ethyl for
High-Cardiovascular Risk Adults (MITIGATE) sponsored by Kaiser
Permanente.
This presentation of CardioLink-9 study results
was one of multiple data presentations at the NLA Scientific
Sessions supported by Amarin. Additional information on NLA
Scientific Sessions 2020 can be found here.
Audio Webcast InformationAmarin
will host an audio webcast on Monday, December 14, 2020, at 8:00
a.m. EST to further discuss these and other VASCEPA-related
findings presented during the NLA Scientific Sessions 2020. The
discussion will include various clinicians and scientists and will
be moderated by Amarin’s chief medical officer, Craig Granowitz,
M.D., Ph.D. To listen please register here, listen live on the
investor relations section of the company's website at
www.amarincorp.com, or via telephone by dialing 877-407-8033 within
the United States, 201-689-8033 from outside the United States. Any
opinions or views expressed by the clinicians and scientists on the
audio webcast are theirs alone. They have neither been scripted nor
previewed by Amarin. While Amarin respects the scientific opinions
of these clinicians and scientists, Amarin takes no responsibility
for those opinions. Rather, this audio webcast is intended to
provide summaries of recently presented scientific data for
consideration by Amarin’s investors.
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. VASCEPA is
not yet approved and available in any other countries. Amarin, on
its own or 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 COVID-19Current
understanding of the biology of COVID-19 is that patients that have
or are at high risk for developing atherosclerotic cardiovascular
disease (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
Scientific Rationale for Study of
VASCEPA in COVID-19 Patients 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
Ongoing preclinical and clinical research may
provide further insights into the scientific and clinical
understanding of these hypothetical effects of VASCEPA in COVID-19
disease mitigation. Whereas vaccines are intended to help eradicate
the virus from proliferating, other therapeutics under development
and clinical testing such as antibodies or other medicines may play
roles in the treatment of patients in various settings across the
infection and recovery continuum.
For more information on studies of VASCEPA in COVID-19 patients,
see the frequently asked question entry on Amarin’s corporate
website, here.
About Cardiovascular RiskThe
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, there are 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)
CapsulesVASCEPA (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 UseVASCEPA 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 = 4089n (%) |
Incidence Rate (per 100 patient
years) |
N = 4090n (%) |
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 impact of VASCEPA in various
clinical uses. 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 such as further clinical evaluations failing to
confirm earlier findings. 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
AmarinInvestors 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
InformationInvestor Inquiries:Investor RelationsAmarin
Corporation plcIn U.S.: +1 (908) 719-1315 IR@amarincorp.com
(investor inquiries)
Solebury Troutamarinir@troutgroup.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028 PR@amarincorp.com (media inquiries)
1 Cummings MJ, Baldwin MR, Abrams D, et al.
Epidemiology, clinical course, and outcomes of critically ill
adults with COVID-19 in New York City: a prospective cohort study.
Lancet. 2020; (published online May 19.)
https://doi.org/10.1016/S0140-6736(20)31189-22 Zhou F, Yu T, Du R,
et al. Clinical course and risk factors for mortality of adult
inpatients with COVID-19 in Wuhan, China: a retrospective cohort
study. Lancet. 2020;395(10229):1054-1062.3 Mehta P, McAuley DF,
Brown M, et al. COVID-19: consider cytokine storm syndromes and
immunosuppression. Lancet. 2020;395(10229):1033‐1034.4 Panigrahy D,
Gilligan MM, Huang S, et al. Inflammation resolution: a
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