– 39% of participants with low baseline
Hepatitis B surface antigen (HBsAg) achieved HBsAg loss with
tobevibart + elebsiran, and 46% with tobevibart + elebsiran +
pegylated interferon alfa –
– No new safety concerns were identified, and
treatment-emergent adverse events were generally mild to moderate
–
– Late-breaking oral presentation of MARCH Part
B study results at the American Association for the Study of Liver
Diseases (AASLD) The Liver Meeting® –
– Key functional cure data from 24-week
follow-up expected in Q2 2025 –
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced
end-of-treatment data from Part B of the MARCH Phase 2 clinical
study evaluating combinations of tobevibart and elebsiran, with or
without pegylated interferon alfa (PEG-IFNα), in participants with
chronic hepatitis B. The study demonstrated promising rates of
hepatitis B surface antigen (HBsAg) loss (seroclearance) in
participants with low baseline HBsAg (<1000 IU/mL) in both
combination regimens. The efficacy and safety profile support
continued development to evaluate the potential to achieve a
functional cure. Detailed data will be presented in a late-breaking
oral presentation at the American Association for the Study of
Liver Diseases (AASLD) The Liver Meeting®, in San Diego, CA,
on November 18 at 5:00 p.m. PT. Vir Biotechnology will host an
investor conference call on November 19, at 5.15 a.m. PT / 8.15
a.m. ET.
Chronic hepatitis B (CHB) is a long-lasting, inflammatory liver
disease caused by the hepatitis B virus (HBV)1. The World Health
Organization estimates that 254 million people live with CHB, and
an estimated 1.1 million yearly deaths are associated with the
disease2. Complications from CHB may include liver cirrhosis, liver
failure and liver cancer3. Although CHB can be treated, there is no
cure1.
Participants in the trial received tobevibart and elebsiran
alone (doublet regimen) or in combination with PEG-IFNα (triplet
regimen). This analysis includes data from 51 participants in the
doublet regimen arm and 27 participants in the triplet regimen arm
at the end of treatment. Tobevibart was administered at 300 mg
every 4 weeks; elebsiran, at 200 mg every 4 weeks; and PEG-IFNα at
180 µg weekly. Study primary endpoints include HBsAg seroclearance
(defined as HBsAg below the lower limit of quantification) and
treatment-emergent adverse events (TEAEs) at end of treatment.
Secondary endpoints include anti-HBs seroconversion (defined as
development of anti-HBs≥10 mIU/mL) at end of treatment.
The doublet and triplet regimens resulted in HBsAg loss at the
end of treatment in 39% (7/18) and 46% (5/11) of participants with
baseline HBsAg<1,000 IU/mL, respectively. The proportion of
participants with varying baseline HBsAg levels who achieved HBsAg
loss at end of treatment was 16% (8/51) for the doublet and 22%
(6/27) for the triplet regimen. The doublet regimen resulted in 50%
(4/8) of participants who had achieved HBsAg loss also achieving
anti-HBs seroconversion. All participants with HBsAg loss at the
end of treatment who received the triplet regimen achieved anti-HBs
seroconversion (100%, 6/6). Participants with HBsAg seroclearance
at end of treatment who meet eligibility criteria will discontinue
treatment. Functional cure assessment will occur 24 weeks after
treatment discontinuation.
“People living with chronic hepatitis B must settle for
life-long treatments that don’t eliminate the risk of disease
progression to liver cancer,” said Edward J. Gane, M.D., Professor
of Medicine at the University of Auckland, New Zealand and Chief
Hepatologist, Transplant Physician and Deputy Director of the New
Zealand Liver Transplant Unit at Auckland City Hospital. “These
latest data at end of treatment are encouraging as they suggest
that tobevibart in combination with elebsiran could be key
components for a hepatitis B functional cure. I look forward to the
further results from this study anticipated next year.”
The safety and tolerability profile of tobevibart and elebsiran
was consistent with prior studies, with no new safety concerns
identified. TEAEs were generally mild or moderate.
“At Vir Biotechnology our ambition is to develop a functional
cure for chronic hepatitis B following a finite treatment regimen.
The MARCH data suggests that tobevibart and elebsiran can clear
HBsAg and re-ignite the immune system, producing antibodies to
potentially keep the virus under control,” said Mark Eisner, M.D.,
M.P.H., Executive Vice President and Chief Medical Officer, Vir
Biotechnology. “We are encouraged by these results and eagerly
anticipate the functional cure data in 2025, as it will be decisive
for the next steps of clinical development.”
The data will be presented in the oral presentation Tobevibart
(VIR-3434) and elebsiran (VIR-2218) with or without pegylated
interferon alfa-2a for the treatment of chronic HBV infection: end
of treatment results after 48 weeks of therapy (MARCH study) by
Edward Gane, M.D., during a late breaking parallel session at AASLD
The Liver Meeting® on November 18 at 5:00 pm PT.
Investor Conference Call
Vir Biotechnology will host an investor conference call on
November 19, 2024 at 5:15 a.m. PT / 8:15 a.m. ET. A live webcast
will be available on https://investors.vir.bio/ and will be
archived on www.vir.bio for 30 days.
About the Phase 2 MARCH Trial
MARCH is a Phase 2 study to evaluate the safety, tolerability,
and efficacy of regimens containing tobevibart (VIR-3434),
elebsiran (VIR-2218), alone or in combination with pegylated
interferon alfa in patients with chronic hepatitis B. This Phase 2
study is a multi-center, open-label, non-randomized study. Primary
endpoints include HBsAg seroclearance (defined as HBsAg below lower
limit of quantification) and treatment-emergent adverse events
(TEAEs) at end of treatment, as well as HBsAg loss at 24 weeks
post-end of treatment. Secondary endpoints include anti-HBs
seroconversion (defined as development of anti-HBs≥10mIU/mL) at end
of treatment. Participants who achieve HBsAg seroclearance at end
of treatment will discontinue treatment, and functional cure
(evaluated as sustained off-treatment HBsAg loss) assessment will
occur 24 weeks after treatment discontinuation. More information
about this trial can be found at clinicaltrials.gov
(NCT04856085).
About Tobevibart
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, which incorporates
Xencor’s Xtend™ and other Fc technologies, has been engineered to
have an extended half-life and was identified using Vir’s
proprietary monoclonal antibody discovery platform. 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
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 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 programs across several
clinically validated targets in solid tumor indications. 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.
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.
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/20241115935599/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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