- 28% and 32% significant reductions in first and total
strokes, respectively, demonstrated with VASCEPA compared to
placebo, as well as reductions in first and total ischemic strokes
each by 36%, without increasing hemorrhagic stroke, in
statin-treated patients with elevated cardiovascular
- Consistent reductions in overall stroke and in ischemic
stroke observed across multiple subgroups
- Administration of pure icosapent ethyl, VASCEPA,
represents a novel clinical approach to stroke
TORONTO, March 17, 2021 /CNW/ - HLS Therapeutics Inc.
("HLS" or the "Company") (TSX: HLS), a specialty pharmaceutical
company focusing on central nervous system and cardiovascular
markets, announces the presentation of REDUCE-IT® STROKE at the
International Stroke Conference 2021, being held virtually from
March 17 – March 19, 2021, adding to the growing body of
knowledge on the clinical impact of VASCEPA® (icosapent ethyl).
These new analyses supported by Amarin Corporation plc ("Amarin")
were 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.
"The REDUCE-IT STROKE analyses provide important data supporting
a new approach to prevent strokes using icosapent ethyl in
appropriate patients," commented Dr. Deepak
L. Bhatt, M.D., M.P.H., Executive Director of Interventional
Cardiovascular Programs at Brigham
and Women's Hospital, Professor of Medicine at Harvard Medical School, and principal investigator
of REDUCE-IT. "The findings of benefit in at-risk patients include
significant reductions in overall strokes and in ischemic strokes.
Importantly, with respect to safety, we did not observe any
significant increase in hemorrhagic stroke. These results further
strengthen the case for pure eicosapentaenoic acid (EPA) in the
form of prescription icosapent ethyl as a key intervention beyond
statins for stroke prevention in studied patients."
The REDUCE-IT STROKE analyses examined stroke rates across the
enrolled patient population (n=8179). Enrolled patients were
required to be treated with statins and other conventional
therapies, and all patients had either established cardiovascular
disease or diabetes and had other cardiovascular risk factors such
as elevated triglyceride levels. Event rates for time to first
fatal or nonfatal stroke were 2.4% for VASCEPA vs. 3.3% for placebo
for a relative risk reduction (RRR) of 28% (p=0.01). Ischemic
stroke time to first event rates were 2.0% for VASCEPA vs. 3.0% for
placebo for a RRR of 36% (p=0.002). Hemorrhagic stroke occurred at
low rates with no significant difference for VASCEPA vs. placebo
(0.3% vs 0.2%; p=0.55).
Stroke is a major and often debilitating cardiovascular event
significantly impacting not only patients and their loved ones, but
also the healthcare system. Patients with elevated triglycerides
despite statin therapy have increased risk for stroke-related
events. An estimated 1.6 million Canadians have heart disease or
are living with the effects of a stroke, according to the Public
Health Agency of Canada. Among
seniors, 14.8% of those ages 65 to 74 years report having heart
disease, with the proportion climbing to 22.9% over age 75. In this
same age group, 7.1% of Canadians report living with the effects of
a stroke. There is also concern that cardiovascular disease could
increase because of increased prevalence of obesity and diabetes,
which are two of its risk factors1.
"Strokes significantly impact the healthcare system, driving
substantial immediate and long-term costs," said Jason Gross, VP Scientific Affairs, HLS. "The
subgroup data presented at ISC 2021 provide new insight into the
unique potential benefits of VASCEPA administration on alleviating
the societal burden of strokes."
The REDUCE-IT STROKE abstract received the prestigious Paul
Dudley White International Scholar Award, recognizing the authors
with the highest ranked abstract across the United States at the International Stroke
Conference 2021. The esteemed Paul Dudley
White Award is named in honor of one of Boston's most revered cardiologists, Dr.
Paul Dudley White, who was a
founding father of the American Heart Association and an early
leader in preventive cardiology.
REDUCE-IT was designed and powered for the primary composite
endpoint, of which stroke was one of five prespecified components;
it was not powered for subgroup analysis. Stroke was a prespecified
secondary endpoint within the testing hierarchy; ischemic stroke
was a prespecified tertiary endpoint; stroke subgroup analyses were
post hoc. No information was collected on stroke related
disability, such as Rankin scores.
Additional information on ISC 2021 can be found here.
ABOUT VASCEPA (ICOSAPENT ETHYL) CAPSULES
(icosapent ethyl) capsules are the first-and-only prescription
treatment comprised solely of the active ingredient, icosapent
ethyl (IPE), a unique form of eicosapentaenoic acid.
VASCEPA was approved by Health Canada, was added to Health
Canada's Register of Innovative Drugs and benefits from data
protection for a term of eight years, as well as being the subject
of multiple issued and pending patents based on its unique
clinical profile. HLS in-licensed the exclusive rights to VASCEPA
for the Canadian market from Amarin Corporation (NASDAQ:AMRN).
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
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.