Vir Biotechnology Receives FDA IND Clearance and Fast Track Designation for Tobevibart and Elebsiran for the Treatment of Chronic Hepatitis Delta Infection
26 Juni 2024 - 2:05PM
Business Wire
Fast Track designation follows positive
preliminary Phase 2 trial data presented at the European
Association for the Study of the Liver Congress 2024 and
underscores the unmet need for people living with chronic hepatitis
delta
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the
U.S. Food and Drug Administration (FDA) has cleared its
investigational new drug (IND) application and granted Fast Track
designation for the combination of tobevibart and elebsiran for the
treatment of chronic hepatitis delta infection. Tobevibart, an
investigational monoclonal antibody, and elebsiran, an
investigational small interfering ribonucleic acid, are currently
being evaluated in the Company’s Phase 2 SOLSTICE hepatitis delta
clinical trial, with complete 24-week treatment data on track to be
reported in the fourth quarter.
“The IND clearance and Fast Track designation from the FDA,
along with the encouraging preliminary data from our Phase 2
hepatitis delta trial, underscore the potential of tobevibart and
elebsiran to transform the treatment landscape for people living
with this severe and life-threatening disease,” said Marianne De
Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. “We are
committed to working closely with health authorities to bring this
potential groundbreaking treatment to patients as quickly as
possible, addressing a critical unmet medical need.”
The FDA’s Fast Track designation is intended to facilitate the
development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need. The World Health
Organization considers hepatitis delta to be the most severe form
of chronic viral hepatitis due to more rapid progression towards
liver cancer and liver-related death. It is estimated that at least
12 million people are living with chronic hepatitis delta
globally.
In June, the Company announced preliminary Phase 2 SOLSTICE
trial data which suggests treatment with tobevibart alone or in
combination with elebsiran was generally well tolerated and
participants achieved high rates of virologic response at weeks 12
and 24, durable virologic response through 48 weeks, and high rates
of ALT normalization. The complete 24-week treatment data is
expected in the fourth quarter. The Company is working to expedite
the initiation of its next study, the ECLIPSE trial. The
open-label, randomized, controlled ECLIPSE trial is designed to
support potential registration and will evaluate the safety and
efficacy of a monthly-administered subcutaneous injection of
tobevibart and elebsiran using the current standard of care therapy
as a comparator.
About the Phase 2 SOLSTICE Trial
The SOLSTICE trial (NCT05461170) is evaluating the safety,
tolerability and efficacy of tobevibart and elebsiran for the
treatment of people living with chronic hepatitis delta. One cohort
is evaluating the combination of tobevibart and elebsiran dosed
every 4 weeks with a second cohort evaluating tobevibart
monotherapy every 2 weeks. Approximately 50% of participants have
compensated cirrhosis.
About Tobevibart (VIR-3434)
Tobevibart is an investigational subcutaneously administered
antibody designed to inhibit entry of hepatitis B and hepatitis
delta viruses into hepatocytes, neutralize both hepatitis B virus
and hepatitis delta virus virions, 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 have an extended half-life and was identified using
Vir’s proprietary monoclonal antibody discovery platform.
About Elebsiran (VIR-2218)
Elebsiran is an investigational subcutaneously administered
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. Vir believes
it has the potential to 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 clinical effects of tobevibart
and elebsiran, the potential benefits, safety and efficacy of
tobevibart and elebsiran, data from Vir’s multiple ongoing trials
evaluating tobevibart and elebsiran, the ability of tobevibart and
elebsiran (as monotherapies or combination therapies) to treat
and/or prevent chronic hepatitis Delta (CHD) or chronic hepatitis B
virus (CHB), Vir’s plans and expectations for its CHD and CHB
programs, the timing and outcome of Vir’s planned interactions with
the FDA, Vir’s ability to realize the benefits from receiving the
Fast Track designation from the FDA, whether Vir maintains Fast
Track designation and/or receives any additional accelerated
development paths from the FDA for tobevibart and elebsiran (as
monotherapies or combination therapies) to treat and/or prevent CHD
or CHB, timing and enrollment for Vir’s ECLIPSE trial, and risks
and uncertainties associated with drug development and
commercialization. Many factors may cause differences between
current expectations and actual results, including that receiving
Fast Track designation might not result in a more expedited
development or regulatory review process, and such a designation
does not increase the likelihood that the combination of tobevibart
and elebsiran for the treatment of chronic hepatitis delta
infection will receive marketing approval in the United States; the
Fast Track designation does not change the standards for regulatory
approval; the FDA may later decide that the combination of
tobevibart and elebsiran for the treatment of chronic hepatitis
delta infection no longer meets the conditions for qualification or
that the time period for FDA review or approval will not be
shortened; 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/20240626614229/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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