-- First Phase 2 Clinical Trial to Combine
Immunomodulation and Antigen Suppression Approaches in HBV Cure
Research --
Gilead Sciences, Inc. (NASDAQ: GILD) and Vir Biotechnology, Inc.
(NASDAQ: VIR) today announced that the companies have entered into
a clinical collaboration to evaluate novel therapeutic combination
strategies aimed at developing a functional cure for chronic
hepatitis B virus (HBV).
The companies plan to initiate a Phase 2 trial evaluating
combination therapy for both treatment-experienced and
treatment-naïve people living with HBV. The multi-arm trial will
evaluate different combinations of selgantolimod, Gilead’s
investigational TLR-8 agonist; VIR-2218, Vir’s investigational
small interfering ribonucleic acid (siRNA); and a
commercially-sourced, marketed PD-1 antagonist. People in the trial
with HBV treatment experience may also receive Gilead’s Vemlidy®
(tenofovir alafenamide fumarate, TAF). The primary outcome of the
study will be the proportion of patients achieving a functional
cure, defined as an off-therapy loss of hepatitis B surface antigen
(HBsAg) and HBV DNA from the serum.
Both companies retain full rights to their individual product
candidates and will discuss the potential path forward for any
future combination studies based on the outcome of the Phase 2
trial.
“Gilead has a two-decade commitment to people with hepatitis B
and we have worked tirelessly to bring new treatments forward with
the goal of helping to improve their lives,” said Anuj Gaggar, Vice
President, Clinical Research, Virology at Gilead Sciences. “We
believe that selgantolimod and VIR-2218 have the potential to be
best-in-class therapeutics and could provide a compelling new
combination approach to a functional cure for HBV.”
“We are enthusiastic about this collaboration,” said Phil Pang,
MD, PhD, Chief Medical Officer of Vir Biotechnology. “We believe a
functional cure for the majority of patients will require a
reduction of the levels of circulating viral proteins together with
an immune boost to stimulate the production of new T-cells that can
bring the infection under control. We believe that this
collaboration with Gilead adds a novel and significant new
combination to our efforts to find a cure for HBV.”
HBV affects more than 290 million people worldwide. Globally,
HBV is a leading cause of liver cancer and each year it is
estimated that more than 800,000 people die of HBV-related liver
disease. While current antiviral therapies result in sustained HBV
viral suppression, they rarely completely clear the virus and
therefore people with HBV require lifelong therapy.
The safety and efficacy of selgantolimod and VIR-2218 have not
been established. They are investigational compounds, not approved
by the U.S. Food and Drug Administration (FDA) or any other
regulatory authority.
U.S. Important Safety Information and
Indication for VEMLIDY
IMPORTANT SAFETY INFORMATION
BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF
HEPATITIS B
- Discontinuation of anti-hepatitis B therapy, including
VEMLIDY, may result in severe acute exacerbations of hepatitis B.
Hepatic function should be monitored closely with both clinical and
laboratory follow-up for at least several months in patients who
discontinue anti-hepatitis B therapy, including VEMLIDY. If
appropriate, resumption of anti-hepatitis B therapy may be
warranted.
Warnings and Precautions
- Risk of Development of HIV-1 Resistance in HBV/HIV-1
Coinfected Patients: Due to this risk, VEMLIDY alone should not
be used for the treatment of HIV-1 infection. Safety and efficacy
of VEMLIDY have not been established in HBV/HIV-1 coinfected
patients. HIV antibody testing should be offered to all
HBV-infected patients before initiating therapy with VEMLIDY, and,
if positive, an appropriate antiretroviral combination regimen that
is recommended for HBV/HIV-1 coinfected patients should be
used.
- New Onset or Worsening Renal Impairment: Cases of acute
renal failure and Fanconi syndrome have been reported with the use
of tenofovir prodrugs. In clinical trials of VEMLIDY, there have
been no cases of Fanconi syndrome or proximal renal tubulopathy
(PRT). Patients with impaired renal function and/or taking
nephrotoxic agents (including NSAIDs) are at increased risk of
renal-related adverse reactions. Discontinue VEMLIDY in patients
who develop clinically significant decreases in renal function or
evidence of Fanconi syndrome. Monitor renal function in all
patients – See Dosage and Administration.
- Lactic Acidosis and Severe Hepatomegaly with Steatosis:
Fatal cases have been reported with the use of nucleoside analogs,
including tenofovir DF. Discontinue VEMLIDY if clinical or
laboratory findings suggestive of lactic acidosis or pronounced
hepatotoxicity develop, including hepatomegaly and steatosis in the
absence of marked transaminase elevations.
Adverse Reactions
Most common adverse reactions (incidence ≥5%; all grades) were
headache, abdominal pain, cough, back pain, fatigue, nausea,
arthralgia, diarrhea, and dyspepsia.
Drug Interactions
- Coadministration of VEMLIDY with drugs that reduce renal
function or compete for active tubular secretion may increase
concentrations of tenofovir and the risk of adverse reactions.
- Coadministration of VEMLIDY is not recommended with the
following: oxcarbazepine, phenobarbital, phenytoin, rifabutin,
rifampin, rifapentine, or St. John’s wort. Such coadministration is
expected to decrease the concentration of tenofovir alafenamide,
reducing the therapeutic effect of VEMLIDY. Drugs that strongly
affect P-glycoprotein (P-gp) and breast cancer resistance protein
(BCRP) activity may lead to changes in VEMLIDY absorption.
Consult the full prescribing information for VEMLIDY for more
information on potentially significant drug interactions, including
clinical comments.
Dosage and Administration
- Testing Prior to Initiation: HIV infection.
- Prior to or when initiating, and during treatment: On a
clinically appropriate schedule, assess serum creatinine, estimated
creatinine clearance, urine glucose, and urine protein in all
patients. In patients with chronic kidney disease, also assess
serum phosphorus.
- Dosage in Adults: 1 tablet taken once daily with
food.
- Renal Impairment: Not recommended in patients with end
stage renal disease (ESRD; eCrCl <15 mL/min) who are not
receiving chronic hemodialysis; in patients on chronic
hemodialysis, on hemodialysis days, administer VEMLIDY after
completion of hemodialysis treatment.
- Hepatic Impairment: Not recommended in patients with
decompensated (Child-Pugh B or C) hepatic impairment.
INDICATION
VEMLIDY is indicated for the treatment of chronic hepatitis B
virus (HBV) infection in adults with compensated liver disease.
Please click here to see full Prescribing Information for
VEMLIDY, including BOXED WARNING.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
About Vir Biotechnology
Vir Biotechnology is a clinical-stage immunology company focused
on combining immunologic insights with cutting-edge technologies to
treat and prevent serious infectious diseases. Vir has assembled
four technology platforms that are designed to stimulate and
enhance the immune system by exploiting critical observations of
natural immune processes. Its current development pipeline consists
of product candidates targeting SARS-CoV-2, hepatitis B virus,
influenza A, human immunodeficiency virus and tuberculosis. For
more information, please visit www.vir.bio.
Gilead Forward-Looking Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the risk that Gilead may not realize the potential
benefits of the collaboration with Vir Biotechnology, the
possibility of unfavorable results from clinical trials involving
Vemlidy and selgantolimod and the possibility that Gilead may be
unable to initiate or complete one or more of such trials in the
currently anticipated timelines or at all. Further, it is possible
that Gilead may make a strategic decision to discontinue
development of selgantolimod and any combination therapies, or that
the parties may make a strategic decision to discontinue their
collaboration at any time, and as a result, selgantolimod and any
combination therapies may never be successfully commercialized.
These risks, uncertainties and other factors could cause actual
results to differ materially from those referred to in the
forward-looking statements. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2020, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
Vir 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 “aim,” “will,” “may,” “potential,” “plan,”
“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. Each of these
forward-looking statements involves risks and uncertainties. Actual
results may differ materially from these forward-looking
statements. Forward-looking statements contained in this press
release include statements regarding the clinical collaboration
between Vir and Gilead Sciences, the ability to develop a
functional cure for chronic HBV, the initiation of a Phase 2 trial
of VIR-2218 to evaluate it as a combination therapy, VIR-2218’s
ability to stimulate an effective immune response and the effects
of including ESC+. Many factors may cause differences between
current expectations and actual results, including unexpected
safety, tolerability, or immunogenicity data or results observed
during the Phase 2 trial, challenges in clinical site activation
rates or clinical trial enrollment rates that are lower than
expected, the failure to achieve the primary outcome of the study,
changes in expected or existing competition, delays in or
disruptions to Vir’s business or clinical trials due to the
COVID-19 pandemic, geopolitical changes, or other external factors,
and unexpected litigation or other disputes. 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.
U.S. Prescribing Information for Vemlidy
including BOXED WARNING, is available at www.gilead.com.
Vemlidy, Gilead and the Gilead logo are
registered trademarks of Gilead Sciences, Inc., or its related
companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210112005578/en/
GILEAD CONTACTS: Monica Tellado, Investors (650)
522-5132
Darcy Bowman, Media +353 (87) 382-6777
VIR CONTACTS: Neera Ravindran, M.D., Investors +1
415-506-5256
Cara Miller, Media +1 415-941-6746
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