- Results presented in Late Breaker session at National
Lipid Association Scientific Sessions 2020
- Vascepa COVID-19 CardioLink-9 Randomized Trial suggests
improvement in patient-reported COVID-19 symptoms while achieving
its primary endpoint by demonstrating a 25% reduction in
high-sensitivity C-reactive protein (hsCRP) with encouraging
short-term safety and tolerability data using Vascepa loading
- Vascepa administration resulted in a significant 52%
reduction of the total patient-reported symptom outcome prevalence
score as compared to a 24% reduction in the usual care
- Larger follow-on clinical studies have commenced of
Vascepa as a therapeutic option in COVID-19 settings, anticipated
to be completed in 2021
TORONTO, Dec. 14, 2020 /CNW/ - HLS Therapeutics Inc.
("HLS" or the "Company") (TSX: HLS), a specialty pharmaceutical
company focusing on central nervous system and cardiovascular
markets, 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 the COVID-19
CardioLink-9 Trial. "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
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 Corporation plc and by HLS. 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
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.
HLS 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.
Gilbert Godin, CEO of HLS
commented on the Cardiolink-9 trial: "We are pleased with the
encouraging reports from this pilot study. We look forward to
gathering results from other trials underway to understand the
various ways that Vascepa may help in dealing with this
AMARIN AUDIO WEBCAST INFORMATION
Amarin 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. 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.
ABOUT HLS THERAPEUTICS INC.
Formed in 2015, HLS is a
specialty pharmaceutical company focused on the acquisition and
commercialization of late-stage development, commercial stage
promoted and established branded pharmaceutical products in the
North American markets. HLS's focus is on products targeting the
central nervous system and cardiovascular therapeutic areas. HLS's
management team is composed of seasoned pharmaceutical executives
with a strong track record of success in these therapeutic areas
and at managing products in each of these lifecycle stages. For
more information, please visit: www.hlstherapeutics.com
Current 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
SCIENTIFIC RATIONALE FOR STUDY OF VASCEPA IN COVID-19
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
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
- Anti-inflammatory effects (acute) in pulmonary/lung
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
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.)
2 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.
3 Mehta P, McAuley DF, Brown M, et al. COVID-19: consider cytokine
storm syndromes and immunosuppression. Lancet.
4 Panigrahy D, Gilligan MM, Huang S, et al. Inflammation
resolution: a dual-pronged approach to averting cytokine storms in
COVID-19? Cancer Metastasis Rev. 2020;1–4.
5 Morita M, Kuba K, Ichikawa A, et al. The lipid mediator protectin
D1 inhibits influenza virus replication and improves severe
influenza. Cell. 2013;153:112-25.
6 Das UN. Can Bioactive Lipids Inactivate Coronavirus (COVID-19)?
Arch Med Res. 2020;51(3):282–286.
7 Morita M, Kuba K, Ichikawa A, et al. The lipid mediator protectin
D1 inhibits influenza virus replication and improves severe
influenza. Cell. 2013;153:112-25.
8 Desbois, A.P. (2013). Antimicrobial Properties of
Eicosapentaenoic Acid (C20:5n −3). In Marine Microbiology, S.–K.
Kim (Ed.). doi:10.1002/9783527665259.ch20.
9 Eclov JA, Qian Q, Redetzke R, et al. EPA, not DHA, prevents
fibrosis in pressure overload-induced heart failure: potential role
of free fatty acid receptor 4. J Lipid Res.
10 Ito S, Sano Y, Nagasawa K, et al. Highly purified
eicosapentaenoic acid ameliorates cardiac injury and adipose tissue
inflammation in a rat model of metabolic syndrome. Obes Sci Pract.
11 Mickleborough TD, Tecklenburg SL, Montgomery GS, Lindley MR.
Eicosapentaenoic acid is more effective than docosahexaenoic acid
in inhibiting proinflammatory mediator production and transcription
from LPS-induced human asthmatic alveolar macrophage cells. Clin
12 El Kebir D, Gjorstrup P, Filep JG. Resolvin E1 promotes
phagocytosis-induced neutrophil apoptosis and accelerates
resolution of pulmonary inflammation. Proc Natl Acad Sci U S A.
FORWARD LOOKING INFORMATION
This release includes
forward-looking statements regarding HLS and its business. Such
statements are based on the current expectations and views of
future events of HLS's management. In some cases the
forward-looking statements can be identified by words or phrases
such as "may", "will", "expect", "plan", "anticipate", "intend",
"potential", "estimate", "believe" or the negative of these terms,
or other similar expressions intended to identify forward-looking
statements, including, among others, statements with respect to
HLS's pursuit of additional product and pipeline opportunities in
certain therapeutic markets, statements regarding growth
opportunities and expectations regarding financial performance. The
forward-looking events and circumstances discussed in this release
may not occur and could differ materially as a result of known and
unknown risk factors and uncertainties affecting HLS, including
risks relating to the specialty pharmaceutical industry, risks
related to the regulatory approval process, economic factors and
many other factors beyond the control of HLS. Forward-looking
statements and information by their nature are based on assumptions
and involve known and unknown risks, uncertainties and other
factors which may cause HLS's actual results, performance or
achievements, or industry results, to be materially different from
any future results, performance or achievements expressed or
implied by such forward-looking statement or information.
Accordingly, readers should not place undue reliance on any
forward-looking statements or information. A discussion of the
material risks and assumptions associated with this release can be
found in the Company's Annual Information Form dated March 18, 2020 and Management's Discussion and
Analysis dated November 4, 2020, both
of which have been filed on SEDAR and can be accessed at
www.sedar.com. Accordingly, readers should not place undue reliance
on any forward-looking statements or information. Except as
required by applicable securities laws, forward-looking statements
speak only as of the date on which they are made and HLS undertakes
no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events,
SOURCE HLS Therapeutics Inc.