– Phase 2 SOLSTICE Safety and Efficacy Data in
Hepatitis Delta Trial at Week 24 to Be Presented –
– Oral and Five Poster Presentations Highlight
Important Progress in Hepatitis Delta and Hepatitis B Clinical
Programs, and Deliver Key Insights on the Burden of Disease Among
Patient Segments in Hepatitis Delta –
Vir Biotechnology, Inc. (NASDAQ:VIR) today announced it will
present new data from the Phase 2 SOLSTICE clinical trial
evaluating the efficacy and safety profile of tobevibart, an
investigational monoclonal antibody (mAb), and elebsiran, an
investigational small interfering ribonucleic acid (siRNA) for the
potential treatment of chronic hepatitis delta.
These data will be presented in an oral presentation at the
upcoming American Association for the Study of Liver Diseases
(AASLD) The Liver Meeting®, in San Diego, CA, November 15-19, 2024.
Vir will also present five poster presentations that further
characterize these investigational therapies as well as recent
efforts to improve the assessment and evaluation of hepatitis delta
infection, and insights into the economic burden of hepatitis delta
for patients and society. Vir will also share advances from across
the chronic hepatitis B development program.
“There is an urgent need for effective therapies for people
living with hepatitis delta who can face rapid progression to liver
cirrhosis and liver cancer. We are excited by the latest data from
our hepatitis delta development program, and we look forward to
sharing our latest findings at AASLD as we work to help patients
living with this debilitating condition,” said Mark Eisner, M.D.,
M.P.H., Executive Vice President and Chief Medical Officer, Vir
Biotechnology. “Further, patients living with chronic hepatitis B
face lifelong treatment and an increased risk of cirrhosis and
liver cancer, so developing a functional cure could transform their
lives. We are pleased to share data further characterizing our
investigational therapies as we continue on our mission to advance
a functional cure.”
Vir will be presenting the following abstracts:
- Efficacy and safety of tobevibart (VIR-3434) alone or in
combination with elebsiran (VIR-2218) in participants with chronic
hepatitis delta virus infection: Week 24 primary endpoint analysis
from the Phase 2 SOLSTICE trial Session: Hepatitis D: Natural
History and Treatment Date: Monday, November 18 Time: 6:15 – 6.30
p.m. PT Presenter: Tarik Asselah, M.D., Ph.D., Professor of
Hepatology at the Hôpital Beaujon, APHP, Clichy, France, and at the
University of Paris, and Head of Viral Hepatitis at INSERM UMR1149,
France
- Pharmacokinetics and safety of a single dose of elebsiran
(VIR-2218, siRNA) subcutaneously administered in adult participants
with moderate renal impairment (Poster #1340) Session:
Hepatitis B Date: November 15 Time: 1:00 – 2:00 p.m. PT Presenter:
Li Wang, Associate Director, Clinical Pharmacology, Vir
Biotechnology, Inc.
- Dose-Dependent Effects of Neutralizing Anti-HBs Monoclonal
Antibody VIR-3434 on Hepatitis B Surface Antigen Composition
(Poster #1409) Session: Hepatitis B Date: November 15 Time: 1:00 –
2:00 p.m. PT Presenter: Florian van B�mmel, M.D., Professor of
Medicine, Division of Hepatology, Department of Medicine II,
Leipzig University Medical Center.
- Safety Profile of tobevibart (VIR-3434) and elebsiran
(VIR-2218) for the treatment of chronic hepatitis B and delta (CHB
and CHD) (Poster #1375) Session: Hepatitis B Date: November 15
Time: 1:00 – 2:00 p.m. PT Presenter: Alina Jucov, M.D., Ph.D.,
Arensia Exploratory Medicine GmbH, Düsseldorf, Germany, and Nicolae
Testemitanu, State University of Medicine and Pharmacy, Chişinău,
Moldova.
- Review of evidence to support the use of surrogate endpoints
and fibroscan in hepatitis D infection (Poster #1174) Session:
Hepatitis – Other Infections Date: November 15 Time: 1:00 – 2:00
p.m. PT Presenter: Prajakta Bhounsule, Director, Health Economy and
Marketing, Vir Biotechnology, Inc.
- Assessing economic burden among unique patient segments in
an HDV-infected population (Poster #3294) Session: Health
Services and Public Health Research Date: November 17 Time: 1:00 –
2:00 p.m. PT Presenter: Prajakta Bhounsule, Director, Health
Economy and Marketing, Vir Biotechnology, Inc.
About Tobevibart (VIR-3434)
Tobevibart is an investigational broadly neutralizing monoclonal
antibody targeting the hepatitis B surface antigen. It is designed
to inhibit the entry of hepatitis B and hepatitis delta viruses
into hepatocytes, and to reduce the level of circulating viral and
subviral particles in the blood. Tobevibart was identified using
Vir’s proprietary antibody discovery platform and has been
engineered to have an extended half-life and optimized binding to
immune cells. Tobevibart is administered subcutaneously, and it is
currently in clinical development for treatment of patients with
chronic hepatitis B and patients with chronic hepatitis delta.
About Elebsiran (VIR-2218)
Elebsiran is an investigational hepatitis B virus-targeting
small interfering ribonucleic acid (siRNA) designed to degrade
hepatitis B virus RNA transcripts and limit the production of
hepatitis B surface antigen. Current data indicates that it has the
potential to have direct antiviral activity against hepatitis B
virus and hepatitis delta virus. Elebsiran is administered
subcutaneously, and it is currently in clinical development for
treatment of patients with chronic hepatitis B and patients with
chronic hepatitis delta. It is the first asset in Vir’s
collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical
studies.
About Chronic Hepatitis Delta
Chronic hepatitis delta (CHD) is a long-lasting, inflammatory
liver disease caused by the hepatitis D virus (HDV), which requires
the presence of hepatitis B virus (HBV) for its replication1. CHD
affects nearly 5% of people who have a chronic infection with HBV,
and it is considered by the World Health Organization to be the
most severe form of chronic viral hepatitis2. Co-infection with HDV
accelerates progression towards liver cancer and liver-related
death by almost a decade in comparison to HBV mono-infected
persons, independently of their age3. There is no cure, and
treatment options are limited.
References:
1 NIH National Institute of Diabetes and Digestive and Kidney
Diseases Hepatitis D - NIDDK (nih.gov), accessed September 2024. 2
WHO Hepatitis Delta Factsheet - Hepatitis D (who.int), accessed
September 2024 3 CDC
https://www.cdc.gov/hepatitis/hdv/hdvfaq.htm
About Chronic Hepatitis B
Chronic hepatitis B (CHB) a is a long-lasting, inflammatory
liver disease caused by the hepatitis B virus (HBV)1. The World
Health Organization estimates that 254 million people were living
with CHB infection in 2022, with 1.2 million new infections each
year, and an estimated 1.1 million yearly deaths associated to the
disease2. Complications from CHB may include liver cirrhosis, liver
failure and liver cancer3. Although CHB can be treated, there’s no
cure available today1.
References:
1 CDC Hepatitis B Basics | Hepatitis B | CDC 2 WHO Hepatitis B
Factsheet - Hepatitis B (who.int), accessed September 2024 3 NIH
National Institute of Diabetes and Digestive and Kidney Diseases
Hepatitis B - NIDDK (nih.gov), accessed September 2024.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical
company focused on powering the immune system to transform lives by
discovering and developing medicines for serious infectious
diseases and cancer. Vir’s clinical-stage portfolio includes
infectious disease programs for chronic hepatitis delta and chronic
hepatitis B infections, in addition to multiple oncology programs.
Vir also has a preclinical portfolio of programs across a range of
other infectious diseases and oncologic malignancies. Vir routinely
posts information that may be important to investors on its
website.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “may,” “will,” “plan,” “potential,” “aim,”
“expect,” “anticipate,” “promising” and similar expressions (as
well as other words or expressions referencing future events,
conditions or circumstances) are intended to identify
forward-looking statements. These forward-looking statements are
based on Vir’s expectations and assumptions as of the date of this
press release. Forward-looking statements contained in this press
release include, but are not limited to, statements regarding Vir’s
strategy and plans, the potential clinical effects of tobevibart
and elebsiran, the potential benefits, safety and efficacy of
tobevibart and elebsiran, the timing, nature and significance of
data from Vir’s multiple ongoing trials evaluating tobevibart and
elebsiran, Vir’s plans and expectations for its CHD and CHB
programs, and risks and uncertainties associated with drug
development and commercialization. Many factors may cause
differences between current expectations and actual results,
including unexpected safety or efficacy data or results observed
during clinical trials or in data readouts; the occurrence of
adverse safety events; risks of unexpected costs, delays or other
unexpected hurdles; difficulties in collaborating with other
companies; successful development and/or commercialization of
alternative product candidates by Vir’s competitors; changes in
expected or existing competition; delays in or disruptions to Vir’s
business or clinical trials due to geopolitical changes or other
external factors; and unexpected litigation or other disputes. Drug
development and commercialization involve a high degree of risk,
and only a small number of research and development programs result
in commercialization of a product. Results in early-stage clinical
trials may not be indicative of full results or results from later
stage or larger scale clinical trials and do not ensure regulatory
approval. You should not place undue reliance on these statements,
or the scientific data presented. Other factors that may cause
actual results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
Vir’s filings with the U.S. Securities and Exchange Commission,
including the section titled “Risk Factors” contained therein.
Except as required by law, Vir assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
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version on businesswire.com: https://www.businesswire.com/news/home/20241014730787/en/
Media Arran Attridge Senior Vice President, Corporate
Communications aattridge@vir.bio
Investors Richard Lepke Senior Director, Investor
Relations rlepke@vir.bio
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