Results to be presented show a significant
reduction of Lp(a) levels, favorable safety and tolerability
profile
Akcea Therapeutics, Inc. (NASDAQ: AKCA), an affiliate of Ionis
Pharmaceuticals, Inc., and Ionis Pharmaceuticals,
Inc. (NASDAQ: IONS), today announced that clinical data on
AKCEA-APO(a)-LRx in patients with established cardiovascular
disease (CVD) and elevated levels of lipoprotein(a), or Lp(a),
will be presented at the American Heart Association
Scientific Sessions in Chicago November 10-12, 2018.
AKCEA-APO(a)-LRx is an antisense drug developed using Ionis’
proprietary
LIgand
Conjugated
Antisense,
or LICA technology platform.
AKCEA-APO(a)-LRx is designed to inhibit production of
apolipoprotein(a), or Apo(a) protein, thereby reducing systemic
levels of lipoprotein(a), or Lp(a). Elevated Lp(a) is an
independent, hereditary risk factor for CVD that cannot be well
controlled with lifestyle modifications, such as diet or exercise,
or with treatment using existing cholesterol-lowering therapies. It
is estimated that there are 8 to 10 million treatable patients
living with cardiovascular disease and elevated levels of
Lp(a).
Following is information about the late-breaking presentation of
AKCEA-APO(a)-LRx:
Saturday, November 10, 2018 from 4:15-4:25 pm
CDT
- Safety and Efficacy of AKCEA-APO(a)-LRx to Lower
Lipoprotein(a) Levels in Patients With Established Cardiovascular
Disease: A Phase 2 Dose-Ranging Trial will be presented by Sotirios
Tsimikas, M.D., FACC, FAHA, FSCAI, Univ California San Diego, and
vice president of global cardiovascular development at Ionis
Pharmaceuticals, La Jolla, CA (Session LBS.02 – Late Breaking
Clinical Trial: Novel Approaches to CV Prevention; Main Event
1)
Akcea will have an on-site presence at the meeting at booth 826
in the Science & Technology Hall where attendees can learn more
about TEGSEDI™ (inotersen).
ABOUT AKCEA-APO(a)-LRx AND THE PHASE 2
STUDY
Akcea and Ionis announced positive topline results in September
2018 from the Phase 2 study demonstrating a significant reduction
in Lp (a) and a favorable safety and tolerability profile. Results
from the study showed most patients in the active group achieved
Lp(a) reductions below the established threshold of risk for
cardiovascular disease events. The Phase 2 randomized,
double-blind, placebo-controlled, dose-ranging study evaluated the
safety and efficacy of different doses of AKCEA-APO(a)-LRx in 286
patients with elevated levels of Lp(a) and established
cardiovascular disease. The study had a five to one randomization
testing different doses and dose frequencies of AKCEA-APO(a)-LRx.
Weekly, every other week and monthly doses were tested ranging from
20mg to 60mg. Patients were dosed for at least six months with some
patients dosed up to one year. The primary efficacy endpoint was
the percent change in Lp(a) from baseline at the primary analysis
time point (6 months) compared to placebo.
AKCEA-APO(a)-LRx is an antisense drug that uses Ionis’
advanced LIgand Conjugated Antisense,
or LICA technology. AKCEA-APO(a)-LRx inhibits the production
of apolipoprotein(a), or Apo(a), protein, thereby reducing
Lp(a).
ABOUT
Lp(a)
Lipoprotein(a), or Lp(a) is made up of apo(a) protein bound to LDL
cholesterol and contains oxidized phospholipids, resulting in an
atherogenic, pro-inflammatory and thrombogenic lipoprotein.
Elevated Lp(a) is recognized as an independent, genetic cause of
cardiovascular disease present in approximately 20-30% of the
population. Lp(a) levels are determined at birth and, therefore,
cannot be well controlled with lifestyle modifications, including
diet and exercise.
For additional information about Lp(a), please see the
Lipoprotein(a) Foundation at
http://www.lipoproteinafoundation.org/.
ABOUT THE
AKCEA AND
NOVARTIS COLLABORATION
In January 2017, Akcea entered into an exclusive, worldwide
option and collaboration agreement with Novartis to
develop and commercialize AKCEA-APOCIII-LRx and
AKCEA-APO(a)-LRx. Along with the Phase 2 study of AKCEA-APO(a)-LRx
reported here, Akcea is also conducting a Phase 2b dose-ranging
study for AKCEA-APOCIII-LRx in patients with
hypertriglyceridemia and established cardiovascular disease with
data planned in 2019. The goal of both studies is to choose the
optimal dose and evaluate alternative dose schedules, such as
monthly dosing, for Phase 3 cardiovascular outcomes
studies. Novartis has the option to license each drug
after completion of the Phase 2 dose-ranging study and end-of-Phase
2 meeting with FDA. Upon option exercise for each
drug, Novartis will pay Akcea a $150
million license fee of which 50% will be paid to Ionis. If
licensed, Novartis plans to conduct a global Phase 3
cardiovascular outcome study in high-risk
patients. Novartis will be responsible for worldwide
development and, if approved, co-commercialization activities. As
part of the collaboration, Akcea has the rights to co-commercialize
Akcea-APO(a)-LRx in selected markets, on mutually agreed terms and
conditions.
About Akcea
Therapeutics,
Inc. Akcea Therapeutics, Inc., an
affiliate of Ionis Pharmaceuticals, Inc., is a
biopharmaceutical company focused on developing and commercializing
drugs to treat patients with serious and rare diseases. Akcea is
advancing a mature pipeline of six novel drugs, including
TEGSEDITM (inotersen), WAYLIVRATM (volanesorsen),
AKCEA-APO(a)-LRx, AKCEA-ANGPTL3-LRx, AKCEA-APOCIII-LRx, and
AKCEA-TTR-LRx, all with the potential to treat multiple diseases.
All six drugs were discovered by and are being co-developed with
Ionis, a leader in antisense therapeutics, and are based on Ionis’
proprietary antisense technology. TEGSEDI is approved in the U.S.,
E.U. and Canada. WAYLIVRA is under regulatory review for the
treatment of familial chylomicronemia syndrome, or FCS, and is
currently in Phase 3 clinical development for the treatment of
people with familial partial lipodystrophy, or FPL. Akcea is
building the infrastructure to commercialize its drugs globally.
Akcea is a global company headquartered in Boston, Massachusetts.
Additional information about Akcea is available
at www.akceatx.com.
About Ionis Pharmaceuticals As the leader in
RNA-targeted drug discovery and development, Ionis has created an
efficient, broadly applicable, proprietary antisense technology
platform with the potential to 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 – such as children and
adults with spinal muscular atrophy (SMA). We created
SPINRAZA® (nusinersen)* and are proud to have brought new hope
to the SMA community by developing the first and only approved
treatment for this disease.
Our sights are set on all the patients we have yet to reach with
a pipeline of more than 40 drugs with the potential to treat
patients with cardiovascular disease, rare diseases, neurological
diseases, infectious diseases and cancer. We created TEGSEDI™
(inotersen) the world’s first RNA-targeted therapeutic approved for
the treatment of polyneuropathy in adult patients with hereditary
transthyretin (TTR) amyloidosis (ATTR) that our affiliate, Akcea
Therapeutics, is commercializing. Together with Akcea, we are
also bringing new medicines to patients with cardiometabolic lipid
disorders.
To learn more about Ionis follow us on twitter @ionispharma or
visit http://ir.ionispharma.com/.
*Spinraza is marketed by Biogen.
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-APO(a)-LRx. Any
statement describing Akcea’s or Ionis’ goals, expectations,
financial or other projections, intentions or beliefs, including
the commercial potential of AKCEA-APO(a)-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. As a
result, you are cautioned not to rely on these forward-looking
statements. These and other risks concerning Ionis’ and Akcea’s
programs are described in additional detail in Ionis’ and Akcea’s
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.
For More
Information:
Akcea Investor Contact:Kathleen GallagherVice
President of Communications and Investor Relations
(617)-207-8509kgallagher@akceatx.com
Akcea Media Contact:Bill BerryBerry &
CompanyT: 212 253-8881bberry@berrypr.com
Lynn GranitoBerry & CompanyT: 212
253-8881lgranito@berrypr.com
Ionis Investor Contact:D. Wade Walke, Ph.D.Vice
President, Investor Relations760-603-2741wwalke@ionisph.com
Ionis Media Contact:Roslyn PattersonVice
President, Corporate
Communications760-603-2681rpatterson@ionisph.com
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