Independent RESPECT-EPA Study Now Third in a
Series of Trials to Underscore Cardiovascular
Risk Reduction Benefits of Eicosapentaenoic Acid ("EPA") for
Patients
TORONTO, Nov. 7, 2022
/CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:
HLS), a pharmaceutical company focusing on central nervous system
and cardiovascular markets, today highlighted key data presented at
the American Heart Association ("AHA") 2022 Scientific Sessions
relevant to VASCEPA® (icosapent ethyl) related to
RESPECT-EPA, A Randomized Trial for Evaluation in Secondary
Prevention Efficacy of Combination Therapy - Statin and
Eicosapentaenoic Acid ("EPA").
RESPECT-EPA Third Study to Show
Cardiovascular Benefit Consistent with REDUCE-IT® and
JELIS
The RESPECT-EPA clinical trial is an independent study funded by
the Japanese Heart Foundation. In 2005, the Japan EPA Lipid
Intervention study ("JELIS") first demonstrated a beneficial effect
of highly purified EPA on cardiovascular outcomes in patients with
or without coronary artery disease ("CAD"). In 2019, Amarin
Corporation (NASDAQ: AMRN) published the positive results of its
double-blind placebo-controlled study REDUCE-IT in patients with
cardiovascular risk and elevated TG levels. And now, RESPECT-EPA is
the third study that demonstrated the value of highly purified EPA
in reducing cardiovascular outcomes in patients with CAD.
The late breaking data presented at AHA using 1.8 grams per day
of purified EPA is consistent with the substantial body of evidence
from the REDUCE-IT and JELIS trials, which showed that highly
purified prescription EPA plus statin significantly reduces the
risk of cardiovascular events in high- and very high-risk
statin-treated patients.
Importantly, the study achieved a borderline statistical
significance with a 21.5% reduction in the primary composite
endpoint measuring cardiovascular risk (p value 0.054) and achieved
a statistically significant 26.6% reduction in the secondary
composite endpoint of RESPECT-EPA (p value
0.03).[i]
EPA level matters. In addition, a post-hoc analysis
conducted by the investigators to control for attained EPA levels
yielded a statistically significant 27.5% reduction in the primary
endpoint (p value 0.02).[ii]
"The results of the RESPECT-EPA trial are directionally
consistent with prior outcomes studies of EPA such as REDUCE-IT in
patients with cardiovascular disease," said Gilbert Godin, CEO of HLS. "This adds to the
growing body of evidence supporting the use of EPA for
cardiovascular risk reduction in patients with well treated LDL-C
and persistent cardiovascular risk."
Other data presented at AHA 2022 support sustained low-density
lipoprotein ("LDL") antioxidant effects for EPA in vitro compared
with docosahexaenoic acid ("DHA") or mineral oil. The researchers
concluded that the longer-term antioxidant actions of EPA may
contribute to reduced events independent of placebo
selection.[iii] Additional in vitro data
presented at the meeting found that neither mineral oil nor corn
oil affected rates of LDL oxidation, a central mechanism of
atherosclerosis, even at high
concentrations.[iv]
"We are very pleased with the data presented at AHA 2022, as it
further underscores the clinical and therapeutic utility of
VASCEPA," said Mr. Godin. "Clinicians should make the best choice
possible for their patients and should have confidence in VASCEPA
as a proven treatment option on top of statins to reduce
cardiovascular risk and to help optimize treatment in appropriate
high-risk patients."
Approved by Health Canada following a priority review, VASCEPA
(icosapent ethyl) is the first and only drug in Canada indicated to reduce persistent residual
cardiovascular risk in patients stabilized on a statin, with
elevated triglycerides and other risk factors for cardiovascular
disease. VASCEPA is made up of one active ingredient, icosapent
ethyl, an innovative form of pure EPA. More than 25 clinical
treatment guidelines, consensus statements and scientific
statements from medical societies or journals around the globe
(including the Canadian Cardiovascular Society, Thrombosis Canada
and the Canadian Heart & Stroke Foundation) recommend the use
of icosapent ethyl in at-risk patients.
HLS has in-licensed the exclusive rights to Vascepa for the
Canadian market from Amarin.
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 16, 2022, and
Management's Discussion and Analysis dated August 10, 2022, 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, or otherwise.
REFERENCES
[i] Respect-EPA: Highly purified EPA appears to reduce risks of
CV events in Japanese CAD patients on Statins. American College of
Cardiology.
https://www.acc.org/latest-in-cardiology/articles/2022/11/01/22/00/sun-7pm-respect-epa-aha-2022.
Published November 6, 2022. Accessed
November 6, 2022.
[ii] Respect-EPA: Highly purified EPA appears to reduce risks of
CV events in Japanese CAD patients on Statins. American College of
Cardiology.
https://www.acc.org/latest-in-cardiology/articles/2022/11/01/22/00/sun-7pm-respect-epa-aha-2022.
Published November 6, 2022. Accessed
November 6, 2022.
[iii] Sherratt SC, Libby P, Bhatt DL, Mason P.
Eicosapentaenoic Acid (EPA) inhibits low-density lipoprotein (LDL)
oxidation compared to docosahexaenoic acid (DHA) and mineral oil in
vitro. Circulation. 2022;146:A13685.
[iv] Sherratt SC, Libby P, Bhatt DL, Mason P. High concentration mineral oil, corn
oil and their constitutive fatty acids do not influence low-density
lipoprotein (LDL) oxidation rates in vitro. Circulation.
2022;146:A15024.
SOURCE HLS Therapeutics Inc.