Vir Biotechnology Completes Enrollment of Phase 2 Chronic Hepatitis Delta SOLSTICE Trial Ahead of Schedule
05 Marzo 2024 - 7:05AM
Business Wire
– Over 60 participants dosed in two additional
cohorts; initial data expected in the second quarter –
– Approximately 50% of participants have
compensated cirrhosis –
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that its
Phase 2 SOLSTICE clinical trial evaluating the safety, tolerability
and efficacy of tobevibart and elebsiran for the treatment of
people living with chronic hepatitis delta (CHD) virus has
completed enrollment of its current cohorts one month earlier than
anticipated. This includes over 60 participants in two additional
cohorts – one evaluating tobevibart given every 2 weeks and the
other evaluating the combination of tobevibart and elebsiran given
every 4 weeks. Initial data are expected in the second quarter of
2024.
“The swift completion of enrollment ahead of expectations
reflects the strong patient and physician interest being generated,
and the urgent need for new treatment options for the millions of
underserved hepatitis delta patients,” said Carey Hwang, M.D.,
Ph.D., Vir’s Senior Vice President, Clinical Research. “We are
proud of the continued progress towards our goal of developing a
safe and efficacious chronic therapy to address the significant
treatment gap and look forward to reporting additional data on
these participants this year.”
Of the participants dosed, approximately 50% have compensated
cirrhosis. In the second quarter, the Company expects to report
additional 12-week treatment data on 30 participants (15 per
regimen) and 24-week treatment data on 20 participants (10 per
regimen). Additional 24-week treatment data for all participants is
expected in the fourth quarter of 2024.
SOLSTICE is a Phase 2 multi-center, open-label trial designed to
evaluate the safety, tolerability, and efficacy of tobevibart and
elebsiran in adult participants (age 18 to 69) with CHD infection
receiving nucleot(s)ide reverse transcriptase inhibitor therapy.
Depending on the cohort, trial participants are receiving multiple
doses of tobevibart and elebsiran as either monotherapy or in
combination administered via subcutaneous injection for up to 88
weeks. The primary endpoints of the trial are the proportion of
study participants achieving either a ≥ 2log10 decrease in HDV RNA
compared to baseline or HDV RNA less than the limit of detection
and normalization of alanine transaminase (ALT) at Week 24.
About Tobevibart
Tobevibart is an investigational subcutaneously administered
antibody designed to block entry of hepatitis B and hepatitis delta
viruses into hepatocytes and to reduce the level of virions and
subviral particles in the blood. Tobevibart, which incorporates
Xencor’s Xtend™ and other Fc technologies, has been engineered to
potentially function as a T cell vaccine against hepatitis B virus
and hepatitis delta virus, as well as to have an extended
half-life. Tobevibart was identified using Vir’s proprietary mAb
discovery platform.
About Elebsiran
Elebsiran is an investigational subcutaneously administered
hepatitis B virus-targeting small interfering ribonucleic acid
(siRNA) that Vir believes has the potential to stimulate an immune
response and have direct antiviral activity against hepatitis B
virus and hepatitis delta virus. It is the first siRNA in the
clinic to include Enhanced Stabilization Chemistry Plus (ESC+)
technology to enhance stability and minimize off-target activity,
which potentially could result in an increased therapeutic index.
Elebsiran is the first asset in the Company’s collaboration with
Alnylam Pharmaceuticals, Inc. to enter clinical trials.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is an immunology company focused on
powering the immune system to transform lives by treating and
preventing infectious diseases and other serious conditions,
including viral-associated diseases. Vir has assembled two
technology platforms that are designed to modulate the immune
system by exploiting critical observations of natural immune
processes. Its current clinical development pipeline consists of
product candidates targeting hepatitis delta and hepatitis B
viruses and human immunodeficiency virus. Vir has several
preclinical candidates in its pipeline, including those targeting
influenza A and B, COVID-19, RSV/MPV and HPV. 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 benefits, safety and efficacy of
tobevibart and elebsiran for the treatment of chronic hepatitis
delta; the timing and design of the Phase 2 SOLSTICE clinical
trial, including enrollment and the anticipated timing of data
readouts or presentations; statements regarding Vir’s scientific
and executional expertise; and risks and uncertainties associated
with drug development and commercialization. Many factors may cause
differences between current expectations and actual results,
including risks of unexpected safety or efficacy data or results
observed during the Phase 2 SOLSTICE trial or in data readouts; the
occurrence of adverse safety events; risks of unexpected costs,
delays or other unexpected hurdles; the timing and outcome of Vir’s
planned interactions with regulatory authorities; difficulties in
obtaining regulatory approval; challenges in accessing
manufacturing capacity; clinical site activation rates or clinical
trial enrollment rates that are lower than expected; 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/20240305632917/en/
Media Carly Scaduto Senior Director, External
Communications cscaduto@vir.bio +1 314-368-5189
Investors Richard Lepke Senior Director, Investor
Relations rlepke@vir.bio +1 978-973-9986
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