BOSTON and CARLSBAD, Calif., Aug.
24, 2020 /PRNewswire/ -- Akcea Therapeutics, Inc. (NASDAQ:
AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc.,
and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), today announced
that data from the Phase 2 clinical trial of vupanorsen
(AKCEA-ANGPTL3-LRx), an investigational antisense
therapy being developed to treat patients with certain
cardiovascular diseases, will be presented in a Late Breaking
Clinical Trial Session at the upcoming ESC Congress 2020, the
annual meeting of the European Society of Cardiology, which is
expected to be the world's largest online gathering of
cardiovascular professionals and is taking place August 29-September 1, 2020.
Vupanorsen was developed using Ionis' proprietary LIgand
Conjugated Antisense (LICA) technology platform to reduce the
production of angiopoietin-like 3 (ANGPTL3) protein, a key
regulator of triglyceride and cholesterol metabolism, in the liver.
The Phase 2 dose-ranging clinical trial evaluated the safety
and efficacy of vupanorsen in patients with
hypertriglyceridemia, type 2 diabetes, and non-alcoholic fatty
liver disease (NAFLD).
In November 2019, Akcea and Ionis announced the closing of
the worldwide exclusive licensing agreement with Pfizer
Inc. for vupanorsen (AKCEA-ANGPTL3-LRx). Under
terms of the agreement, Akcea and Ionis received a $250
million upfront license fee, which was split equally between
the two companies. Pfizer is responsible for all development and
regulatory activities and costs beyond those associated with this
Phase 2 study.
Following are details about the late-breaking virtual
presentation at ESC Congress 2020, which will be made available on
the Akcea website:
- Late-Breaking Science in Lipids: ANGPTL3 Antisense
Oligonucleotide to Lower Triglycerides by Daniel Gaudet, M.D., professor of medicine,
Department of Medicine, University of
Montreal
Oral Presentation: Saturday, August 29,
2020, 3:00 a.m.
ET/9:00 a.m. CEST
ABOUT VUPANORSEN (AKCEA-ANGPTL3-LRx)
AKCEA-ANGPTL3-LRx (vupanorsen) is an
investigational antisense therapy being developed to treat patients
with certain cardiovascular diseases. This antisense medicine is
designed to reduce the production of angiopoietin-like 3 (ANGPTL3)
protein, a key regulator of triglyceride and cholesterol
metabolism, in the liver. AKCEA-ANGPTL3-LRx was
developed using Ionis'
advanced LIgand Conjugated Antisense (LICA)
technology platform. The potential therapeutic benefits of ANGPTL3
reduction are supported by the discovery that people with a genetic
deficiency in ANGPTL3 have reduced levels of low-density
lipoprotein cholesterol (LDL-C) and triglycerides, and a decreased
risk of cardiovascular disease.1 In a previous
Phase 1 study, patients treated with
AKCEA-ANGPTL3-LRx achieved robust, dose-dependent
reductions in ANGPTL3, triglycerides, LDL-C, non-HDL-C and total
cholesterol with a positive safety and tolerability
profile.2 AKCEA-ANGPTL3-LRx was
discovered by Ionis and has been co-developed by Akcea and
Ionis.
ABOUT AKCEA THERAPEUTICS
Akcea Therapeutics, Inc., a majority-owned affiliate
of Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), is a
biopharmaceutical company focused on developing and commercializing
medicines to treat patients with serious and rare diseases. Akcea
is commercializing TEGSEDI® (inotersen) and
WAYLIVRA® (volanesorsen), as well as advancing a
mature pipeline of novel medicines, including
AKCEA-APO(a)-LRx, vupanorsen
(AKCEA-ANGPTL3-LRx), AKCEA-APOCIII-LRx, and
AKCEA-TTR-LRx, with the potential to treat multiple
diseases. All six drugs were discovered by Ionis, a leader in
antisense therapeutics, and are based on Ionis' proprietary
antisense technology. TEGSEDI is approved in the U.S., E.U.,
Canada and Brazil, and WAYLIVRA is approved in the
E.U. Akcea is headquartered in Boston and is building the infrastructure
to commercialize its medicines globally. Additional information
about Akcea is available at www.akceatx.com and you can
follow us on Twitter at @akceatx.
ABOUT IONIS PHARMACEUTICALS, INC.
As the leader in RNA-targeted drug discovery and development, Ionis
has created an efficient, broadly applicable, drug discovery
platform called antisense technology that can treat diseases where
no other therapeutic approaches have proven effective. Our drug
discovery platform has served as a springboard for actionable
promise and realized hope for patients with unmet needs. We created
the first and only approved treatment for children and adults with
spinal muscular atrophy as well as the world's first RNA-targeted
therapeutic approved for the treatment of polyneuropathy in adults
with hereditary transthyretin amyloidosis. Our sights are set on
all the patients we have yet to reach with a pipeline of more than
40 novel medicines designed to potentially treat a broad range of
disease, including neurological, cardio-renal, metabolic,
infectious, and pulmonary diseases. To learn more about Ionis
visit www.ionispharma.com and follow us on Twitter
@ionispharma.
AKCEA AND IONIS FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding
the business of Akcea Therapeutics, Inc. and Ionis
Pharmaceuticals, Inc. and the therapeutic and commercial
potential of AKCEA-ANGPTL3-LRx. Any statement describing
Akcea's or Ionis' goals, expectations, financial or other
projections, intentions or beliefs, including the commercial
potential of AKCEA-ANGPTL3-LRx or other of Akcea's
or Ionis' drugs in development is a forward-looking statement and
should be considered an at-risk statement. Such statements are
subject to certain risks and uncertainties, particularly those
inherent in the process of discovering, developing and
commercializing drugs that are safe and effective for use as human
therapeutics, and in the endeavor of building a business around
such drugs. Akcea's and Ionis' forward-looking statements also
involve assumptions that, if they never materialize or prove
correct, could cause its results to differ materially from those
expressed or implied by such forward-looking statements. Although
Akcea's and Ionis' forward-looking statements reflect the good
faith judgment of its management, these statements are based only
on facts and factors currently known by Akcea and Ionis. In
particular, we caution you that our forward-looking statements are
subject to the ongoing and developing circumstances related to the
COVID-19 pandemic, which may have a material adverse effect on our
business, operations and future financial results. As a result, you
are cautioned not to rely on these forward-looking statements.
These and other risks concerning Akcea's and Ionis' programs are
described in additional detail in Akcea's and Ionis' quarterly
reports on Form 10-Q and annual reports on Form 10-K, which are on
file with the SEC. Copies of these and other documents are
available from each company.
In this press release, unless the context requires otherwise,
"Ionis," "Akcea," "Company," "Companies," "we," "our," and "us"
refers to Ionis Pharmaceuticals and/or Akcea
Therapeutics.
Ionis Pharmaceuticals® is a trademark of Ionis
Pharmaceuticals, Inc. Akcea Therapeutics®,
TEGSEDI® and WAYLIVRA® are
trademarks of Akcea Therapeutics, Inc.
References
1. JAMA Cardiol.
2018 Oct 1;3(10):957-966.
2. N Engl J Med. 2017 Jul 20;377(3):222-232.
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SOURCE Akcea Therapeutics, Inc.; Ionis Pharmaceuticals, Inc.