- Analysis Also Found Icosapent Ethyl Was Associated with
a 41% Reduction in Total Events Compared with Placebo
- Subgroup Almost Exclusively Comprised of Patients with
Established Cardiovascular Disease
- Findings Continue to Reinforce the Scientific Data and
Clinical Use of Vascepa® to Reduce Cardiovascular
Risk
- Results Presented November 12,
2023, at the American Heart Association (AHA) Scientific
Sessions 2023 and Simultaneously Published in the European Heart
Journal Open
TORONTO, Nov. 14,
2023 /CNW/ - HLS Therapeutics Inc. ("HLS" or the
"Company") (TSX: HLS), a pharmaceutical company focused on
addressing unmet needs in the treatment of psychiatric disorders
and cardiovascular disease, announces results from new REDUCE-IT
analyses adding to the growing body of knowledge on the clinical
impact of Vascepa (icosapent ethyl). These new analyses show that
among statin-treated patients in a prespecified subgroup with
history of Metabolic Syndrome, but without diabetes at baseline,
the addition of Vascepa (icosapent ethyl) significantly reduced the
risk of first and total cardiovascular events. This subgroup was
almost exclusively comprised of patients with established
cardiovascular disease. The results were presented at the American
Heart Association ("AHA") Scientific Sessions 2023, which took
place November 11 – 13, 2023 in
Philadelphia, PA and were
simultaneously published in the European Heart Journal Open.
It is estimated that 1 in 5 Canadians have Metabolic
Syndrome1, a cluster of 3 or more of 5 risk factors: 1)
waist circumference ≥102 cm in men and ≥88 cm in women, 2) blood
pressure ≥130/85 mmHg, 3) fasting glucose ≥5.6 mmol/L, 4)
triglycerides ≥1.7 mmol/L, and 5) HDL-C <1.00 mmol/L in men and
<1.30 mmol/L in women.
Among patients with Metabolic Syndrome but without diabetes at
baseline (n=2866), those who were allocated to icosapent ethyl
("IPE") treatment with a median follow-up time of 4.9 years
experienced a 29% relative risk reduction for the primary composite
endpoint, defined as cardiovascular death, nonfatal myocardial
infarction, nonfatal stroke, coronary revascularization, or
unstable angina resulting in hospitalization (P <0.0001)
(Absolute Risk Reduction [ARR]=5.9%; number needed to treat
[NNT]=17) and a 41% reduction in total (first plus subsequent)
events (P <0.0001) compared with placebo. The risk for the key
secondary composite endpoint, defined as cardiovascular death,
nonfatal myocardial infarction, or nonfatal stroke was reduced by
20% (P=0.05) and there was a 27% reduction in fatal/nonfatal
myocardial infarction (P=0.03), 47% reduction in urgent/emergent
revascularization (P <0.0001) and 58% reduction in
hospitalization for unstable angina (P <0.0001).
Non-statistically significant reductions were observed in cardiac
arrest (44%) and sudden cardiac death (34%).
The large relative and absolute risk reductions observed
supports IPE as an important therapeutic option for patients with
metabolic syndrome at high cardiovascular risk, despite lacking
robust effects on any metabolic syndrome component.
"The Metabolic Syndrome subgroup analysis from the REDUCE-IT
trial is yet another example of the robust findings from this
landmark clinical trial," said Craig
Millian, CEO of HLS. "These data provide meaningful insight
into the role that icosapent ethyl may play in helping reduce the
risk of cardiovascular events in patients living with metabolic
syndrome without diabetes who have established cardiovascular
disease. With one in five Canadians estimated to be living
with Metabolic Syndrome, the findings are very relevant for
patients who must contend with this disease and for the physicians
who treat them."
Limitations of these analyses, some of which are exploratory in
nature, include the relatively small number of events in certain
subgroups or for certain endpoints, such as cardiac arrest and
sudden cardiac death. In addition, variation in subjective measures
(e.g., waist circumference) may have affected classification of
metabolic syndrome.
HLS has in-licensed the exclusive rights to Vascepa for the
Canadian market from Amarin Corporation plc (NASDAQ: AMRN).
ABOUT METABOLIC SYNDROME
Metabolic Syndrome is a cluster of conditions that increase the
risk of heart disease, stroke and Type 2 diabetes mellitus
("T2DM"). Metabolic Syndrome is defined as the presence of any
three of the following five risk factors: increased blood pressure,
high blood sugar, excess body fat around the waist, low HDL
cholesterol, or elevated/high triglyceride levels.2
Metabolic Syndrome is increasingly common,2 and an
estimated 1 out of 5 people in Canada have it. Metabolic Syndrome is not only
associated with a two-fold increased risk of adverse cardiovascular
disease outcomes (e.g., myocardial infarction, stroke and CV
mortality), even in the absence of T2DM, but in recent years has
also been linked to a variety of pathogenic phenotypes including
heart failure and renal insufficiency.3,4,5
ABOUT CARDIOVASCULAR
DISEASE
Worldwide, cardiovascular disease (CVD) remains the #1 cause of
mortality of men and women.
Multiple primary and secondary prevention trials have
shown a significant reduction of 25% to 35% in the risk
of cardiovascular events with statin therapy, leaving
significant persistent residual risk despite the achievement of
target LDL-C levels.6
Beyond the cardiovascular risk associated with LDL-C, genetic,
epidemiologic, clinical and real-world data suggest that patients
with elevated triglycerides (TG) (fats in the blood), and TG-rich
lipoproteins, are at increased risk for cardiovascular
disease.7, 8, 9, 10
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.11 The primary results of REDUCE-IT were
published in The New England Journal of Medicine in November 201812. The total
events13 and other publications can be found in the
R&D section on the company's website at www.amarincorp.com.
ABOUT HLS THERAPEUTICS
INC.
Formed in 2015, HLS is a 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 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, expectations regarding financial
performance, and the NCIB and ASPP. 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 15, 2023, and
Management's Discussion and Analysis dated November 8, 2023, both of which have been filed
on SEDAR and can be accessed at www.sedarplus.ca. 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, or otherwise.
REFERENCES
1
https://www.metabolicsyndromecanada.ca/mets
|
2 Mayo
Clinic Metabolic Syndrome – Overview:
https://www.mayoclinic.org/diseases-conditions/metabolic-syndrome/symptoms-causes/syc-20351916
|
3 Mottillo S, Filion KB, Genest J,
Joseph L, Pilote L, Poirier P et al. The metabolic syndrome and
cardiovascular risk a systematic review and meta-analysis. J Am
Coll Cardiol 2020;56:1113–1132.
|
4 Burger PM, Koudstaal S, Dorresteijn
JAN, Savarese G, van der Meer MG, de Borst GJ, Mosterd A, Visseren
FLJ; UCC-SMART study group. Metabolic syndrome and risk
of incident heart failure in non-diabetic patients with
established cardiovascular disease.Int J Cardiol.
2023;379:66-75.
|
5 Li X,
Liang Q, Zhong J, Gan L, Zuo L. The Effect of Metabolic Syndrome
and Its Individual Components on Renal Function: A Meta-Analysis. J
Clin Med. 2023;12:1614.
|
6 Ganda
OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive
dyslipidemia therapy in hypertriglyceridemia management. J Am Coll
Cardiol. 2018;72(3):330-343.
|
7 Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145.
|
8 Toth
PP, Granowitz C, Hull M, et al. High triglycerides are associated
with increased cardiovascular events, medical costs, and resource
use: A real-world administrative claims analysis of statin-treated
patients with high residual cardiovascular risk. J Am Heart Assoc.
2018;7(15):e008740.
|
9
Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic
cardiovascular disease - New insights from epidemiology, genetics,
and biology. Circ Res. 2016;118:547-563.
|
10 Nordestgaard BG, Varbo A.
Triglycerides and cardiovascular disease. Lancet.
2014;384:626–635.
|
11 Bhatt DL, Steg PG, Brinton E, et
al., on behalf of the REDUCE-IT Investigators. Rationale and Design
of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent
Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.
|
12 Bhatt DL, Steg PG, Miller M, et
al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk
Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J
Med. 2019;380:11-22
|
13 Bhatt DL, Steg PG, Miller M, et
al., on behalf of the REDUCE-IT Investigators. Effects of Icosapent
Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol.
2019;73:2791-2802.
|
SOURCE HLS Therapeutics Inc.