– Orphan designation in E.U. supports
development of treatments for life-threatening or chronically
debilitating conditions with significant unmet medical need –
– Phase 2 SOLSTICE 24-week primary endpoint
data for tobevibart and elebsiran in chronic hepatitis delta to be
presented today at AASLD The Liver Meeting –
– Positive opinion on E.U. orphan drug
designation follows U.S. FDA fast track designation, highlighting
growing recognition of the potential of tobevibart and elebsiran in
chronic hepatitis delta –
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the
European Medicines Agency (EMA) Committee for Orphan Medicinal
Products (COMP), has issued a positive opinion on the application
for orphan drug designation of tobevibart and elebsiran for the
treatment of chronic hepatitis delta (CHD). This opinion is based
on encouraging preliminary data from the Phase 2 SOLSTICE trial.
Vir Biotechnology will present 24-week data from the Phase 2
SOLSTICE trial at AASLD The Liver Meeting® in San Diego, CA, on
November 18 at 6.15 p.m. PT. An investor conference call is
scheduled for November 19, 2024, at 5.15 a.m. PT / 8.15 a.m.
ET.
CHD is a severe, progressive liver disease caused by the
hepatitis delta virus (HDV)1. It is considered the most aggressive
form of chronic viral hepatitis2, with patients often progressing
to cirrhosis and liver failure within 5 years of infection3.
Currently, there is no approved treatment in the United States, and
treatment options are limited in the European Union and
globally.
“Chronic hepatitis delta dramatically raises the risk of severe
liver disease, including cancer, and eventually death, so new
therapeutic options are urgently needed,” said Mark Eisner, M.D.,
M.P.H., Executive Vice President and Chief Medical Officer, Vir
Biotechnology. “The COMP’s positive opinion on tobevibart and
elebsiran reflects the potential of this combination to address a
critical gap in hepatitis delta care. Our clinical data to date has
been encouraging, suggesting that this approach could meaningfully
improve outcomes for patients living with this devastating
disease.”
The European Commission will evaluate the COMP’s positive
opinion and consider tobevibart and elebsiran for orphan drug
designation. This designation is for medicines intended to treat
rare, life-threatening or chronically debilitating conditions where
no other satisfactory treatment option is available, or where the
medicine can be of significant benefit to those affected by a
specific condition. The designation provides special incentives in
the E.U., including access to specific scientific advice, fee
reductions, and 10 years of market exclusivity once the medicine is
approved.
In June 2024, the U.S. Food and Drug Administration (FDA)
granted fast track designation for the combination of tobevibart
and elebsiran for the treatment of CHD. This designation is
intended to facilitate the development and expedite the review of
drugs to treat serious conditions and fill an unmet medical
need.
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 SOLSTICE Trial
SOLSTICE is a Phase 2 study to evaluate the safety,
tolerability, and efficacy of tobevibart, alone or in combination
with elebsiran, in patients with chronic hepatitis delta. This
Phase 2 study is a multi-center, open-label, randomized study.
Primary endpoints include proportion of participants with
undetectable hepatitis delta virus (HDV) RNA (defined as HDV RNA
equal or greater than 2 log10 decrease from baseline or below limit
of detection) up to week 24, alanine aminotransferase (ALT)
normalization (defined as ALT below upper limit of normal) up to
week 24, and treatment-emergent adverse events (TEAEs) and serious
adverse events (SAEs) up to 118 weeks. Secondary endpoints include
proportion of participants with undetectable HDV RNA and different
timepoints and up to 192 weeks. More information about this trial
can be found at clinicaltrials.gov (NCT05461170).
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 Biotechnology’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
Biotechnology’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. It’s clinical-stage portfolio includes
infectious disease programs for chronic hepatitis delta and chronic
hepatitis B infections and programs across several clinically
validated targets in solid tumor indications. Vir Biotechnology
also has a preclinical portfolio of programs across a range of
other infectious diseases and oncologic malignancies. Vir
Biotechnology routinely posts information that may be important to
investors on its website.
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 What is Hepatitis D - FAQ | CDC
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 Biotechnology’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 Biotechnology’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 Biotechnology’s
multiple ongoing trials evaluating tobevibart and elebsiran, Vir
Biotechnology’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 Biotechnology’s competitors;
changes in expected or existing competition; delays in or
disruptions to Vir Biotechnology’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 Biotechnology’s filings with the U.S. Securities and Exchange
Commission, including the section titled “Risk Factors” contained
therein. Except as required by law, Vir Biotechnology assumes no
obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241118366724/en/
Media Arran Attridge Senior Vice President, Corporate
Communications aattridge@vir.bio
Investors Richard Lepke Senior Director, Investor
Relations rlepke@vir.bio
Vir Biotechnology (NASDAQ:VIR)
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