- Initiation of the Phase 3 program expands Ionis' late-stage
pipeline to 7 medicines in 9 indications
CARLSBAD, Calif., Feb. 1, 2023
/PRNewswire/ -- Ionis Pharmaceuticals, Inc.
(Nasdaq: IONS) today announced that GSK
has initiated two randomized, double-blind,
placebo-controlled Phase 3 studies evaluating the safety and
efficacy of bepirovirsen (formerly
IONIS-HBVRx), an investigational
antisense medicine for the treatment of patients with
chronic hepatitis B infection (CHB).
"The initiation of this Phase 3 program is an important step
closer to delivering novel medicines to HBV patients in need," said
Richard S. Geary, Ph.D., Ionis'
executive vice president and chief development officer. "Promising
Phase 2b results, which included the
possibility for functional cure, offered an early indication that
bepirovirsen has potential to provide significant benefit to
patients living with CHB, a serious chronic health
problem."
Current first-line therapies for patients with CHB can inhibit
viral replication but cannot clear the virus and are generally
taken for life. Bepirovirsen is a potential first-in-class
treatment for CHB, uniquely designed to simultaneously reduce
hepatitis B virus (HBV) replication and suppress viral antigens in
hopes of stimulating innate immunity to help attain functional cure
for patients.
Ionis earned a $15 million
milestone payment from GSK associated with the progression of
bepirovirsen into the Phase 3 clinical studies.
For more information on the Phase 3 clinical studies please
visit B-Well 1 and B-Well 2.
About Hepatitis B Virus Infection
Hepatitis B virus infection is a serious health problem that can
lead to significant and potentially fatal health conditions,
including cirrhosis, liver failure and liver cancer. Chronic
hepatitis B infection is caused by the hepatitis B virus and is a
major global health concern, affecting nearly 300 million people
worldwide.1,2 Chronic HBV infection is one of the most
common persistent viral infections in the world. Currently
available therapies, although effective in reducing circulating HBV
DNA in the blood, do not efficiently inhibit HBV antigen production
and secretion.
About Bepirovirsen
Bepirovirsen (formerly known as IONIS-HBVRx), also
known as GSK3228836, is an investigational antisense medicine
designed to reduce the production of viral proteins associated with
hepatitis B virus (HBV) infection and replication, including
hepatitis B surface antigen, which is present in both acute and
chronic infections and is associated with a poor prognosis in
patients with chronic HBV infection.
Bepirovirsen was discovered and jointly developed with GSK. GSK
licensed bepirovirsen from Ionis in August
2019 under a collaborative development and licensing
agreement.
About Ionis Pharmaceuticals, Inc.
For more than 30 years, Ionis has been the leader in
RNA-targeted therapy, pioneering new markets and changing standards
of care with its novel antisense technology. Ionis currently has
three marketed medicines and a premier late-stage pipeline
highlighted by industry-leading cardiovascular and neurological
franchises. Our scientific innovation began and continues with the
knowledge that sick people depend on us, which fuels our vision to
become the undisputed leader in genetic medicine, utilizing a
multi-platform approach to discover, develop and deliver
life-transforming therapies.
To learn more about Ionis, visit www.ionispharma.com and follow
us on Twitter @ionispharma.
Ionis' Forward-looking Statements
This press release includes forward-looking statements regarding
Ionis' business and the therapeutic and commercial potential of
Ionis' technologies, bepirovirsen and other products in
development. Any statement describing Ionis' goals, expectations,
financial or other projections, intentions or beliefs is a
forward-looking statement and should be considered an at-risk
statement. Such statements are subject to certain risks and
uncertainties, including those related to the impact COVID-19 could
have on our business, and including but not limited to, those
related to our commercial products and the medicines in our
pipeline, and particularly those inherent in the process of
discovering, developing and commercializing medicines that are safe
and effective for use as human therapeutics, and in the endeavor of
building a business around such medicines. 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 Ionis' forward-looking statements reflect the good
faith judgment of its management, these statements are based only
on facts and factors currently known by Ionis. As a result, you are
cautioned not to rely on these forward-looking statements. These
and other risks concerning Ionis' programs are described in
additional detail in Ionis' annual report on Form 10-K for the year
ended Dec. 31, 2021, and the most
recent Form 10-Q quarterly filing, which are on file with the
Securities and Exchange Commission. Copies of these and other
documents are available from the Company.
In this press release, unless the context requires otherwise,
"Ionis," "Company," "we," "our," and "us" refers to Ionis
Pharmaceuticals and its subsidiaries.
Ionis Pharmaceuticals® is a trademark of Ionis
Pharmaceuticals, Inc.
1 Trepo C, et al. Hepatitis B virus infection.
Lancet. 2014 Dec 6; 384(9959):
2053-63. https://doi.org/10.1016/S0140-6736(14)60220-8
2 World Health Organization,
https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
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SOURCE Ionis Pharmaceuticals, Inc.