INDIANAPOLIS and SAN FRANCISCO and LONDON, March 29,
2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY),
Vir Biotechnology, Inc. (NASDAQ: VIR) and GlaxoSmithKline plc
(LSE/NYSE: GSK) today announced topline data from the expanded
Phase 2 BLAZE-4 trial studying low-risk adult patients with mild to
moderate COVID-19. Results showed that investigational bamlanivimab
(LY-CoV555) 700 mg co-administered with VIR-7831 (also known as
GSK4182136) 500 mg demonstrated a 70 percent (p<0.001)
relative reduction in persistently high viral load (>
5.27; cycle threshold value < 27.5) at day 7 compared
to placebo, meeting the primary endpoint.
In addition, bamlanivimab administered with VIR-7831
demonstrated a statistically significant reduction compared to
placebo in the key virologic secondary endpoints of mean change
from baseline to days 3, 5 and 7 in SARS-CoV-2 viral load. There
were no events for the secondary endpoint of COVID-19 related
hospitalization or death by day 29 in either study arm. One patient
(in the treatment arm) visited the emergency room for COVID-19
related symptoms. No serious adverse events were seen with
co-administration of bamlanivimab and VIR-7831.
Bamlanivimab and VIR-7831 bind to different regions of the spike
protein of SARS-CoV-2. Preclinical data suggest the administration
of these two investigational antibodies together may provide
protection against current variants of SARS-CoV-2 that are
resistant to bamlanivimab.
Daniel Skovronsky, M.D.,
Ph.D., Lilly's chief scientific officer and president of Lilly
Research Laboratories said: "The reduction in persistently
high viral load is an important virology endpoint that was
demonstrated in Lilly's Phase 2 BLAZE-1 trial, and subsequently
validated in the Phase 3 trial, to be strongly correlated with the
clinical outcome of COVID-19 related hospitalizations and deaths in
high-risk patients. These virology data support our belief that
bamlanivimab and VIR-7831 together could be a promising option for
COVID-19 treatment."
George Scangos, Ph.D., chief
executive officer of Vir said: "This virologic
evaluation of two antibodies with distinct resistance profiles is
an encouraging advance in our fight against the pandemic. VIR-7831
demonstrated positive results in
the COMET-ICE trial and recent pre-clinical data suggest that
VIR-7831 maintains activity against current circulating variants of
concern. Now, with these exciting new data from the BLAZE-4 trial,
we believe that VIR-7831 has an important role to play as both
monotherapy and in combination with other mAbs. We look forward to
continuing conversations with the FDA about VIR-7831 as monotherapy
and co-administered with bamlanivimab."
Dr. Hal Barron, chief scientific officer and president
R&D, GSK, said: "These early data from the BLAZE-4
trial, coupled with the results of the COMET-ICE trial
demonstrating an 85 percent reduction in progression to
hospitalization or death using VIR-7831, support our hypothesis
that by targeting a highly conserved epitope, VIR-7831 may help
deliver benefits to patients. We're continuing to work with
regulators to bring VIR-7831 as a monotherapy and potentially
co-administered with other monoclonal antibodies to patients in
need."
VIR-7831 is an investigational compound, not approved by the
U.S. Food and Drug Administration (FDA) or any other regulatory
authority. An Emergency Use Authorization (EUA) application for
VIR-7831 has been submitted to the FDA, based on the results of the
COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to
Care Early) trial, which stopped enrollment early based on data
from an interim analysis demonstrating an 85 percent reduction in
hospitalisation or death in patients receiving VIR-7831 as
monotherapy compared to placebo, the primary endpoint of the trial.
GSK and Vir will continue discussions with the European Medicines
Agency (EMA) and other global regulators to make VIR-7831 available
to patients with COVID-19 as soon as possible. The three companies
anticipate engaging with global regulators, including the FDA,
regarding the possible co-administration of bamlanivimab and
VIR-7831 for the treatment of COVID-19.
Important Information about bamlanivimab
Bamlanivimab
has not been approved by the FDA for any use. It is not known if
bamlanivimab is safe and effective for the treatment of
COVID-19.
Bamlanivimab is authorized under an Emergency Use Authorization
only for the duration of the declaration that circumstances exist
justifying the authorization of the emergency use of bamlanivimab
under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
Healthcare providers should review the Fact Sheet for
information on the authorized use of bamlanivimab and mandatory
requirements of the EUA. Please see the FDA Letter of
Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet
for Patients, Parents, and Caregivers (English) (Spanish).
Authorized Use and Important Safety Information
Bamlanivimab 700 mg injection is authorized for use under EUA for
treatment of mild to moderate COVID-19 in adults and pediatric
patients (12 years of age and older weighing at least 40 kg) with
positive results of direct SARS-CoV-2 viral testing, and who are at
high risk for progressing to severe COVID-19 and/or
hospitalization.
Limitations of Authorized Use
- Bamlanivimab is not authorized for use in patients:
-
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to
COVID-19 in those on chronic oxygen therapy due to underlying
non-COVID-19 related comorbidity.
- Benefit of treatment with bamlanivimab has not been observed in
patients hospitalized due to COVID-19. Monoclonal antibodies, such
as bamlanivimab, may be associated with worse clinical outcomes
when administered to hospitalized patients requiring high flow
oxygen or mechanical ventilation with COVID-19.
Important Safety Information
There are limited
clinical data available for bamlanivimab. Serious and unexpected
adverse events may occur that have not been previously reported
with bamlanivimab use.
Hypersensitivity Including Anaphylaxis and
Infusion-Related Reactions
Serious hypersensitivity reactions, including anaphylaxis, have
been observed with administration of bamlanivimab. If signs and
symptoms of a clinically significant hypersensitivity reaction or
anaphylaxis occur, immediately discontinue administration and
initiate appropriate medications and/or supportive care.
Infusion-related reactions have been observed with
administration of bamlanivimab. These reactions may be severe or
life threatening. Signs and symptoms of infusion-related reactions
may include:
- fever, difficulty breathing, reduced oxygen saturation, chills,
fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia,
bradycardia), chest pain or discomfort, weakness, altered mental
status, nausea, headache, bronchospasm, hypotension, hypertension,
angioedema, throat irritation, rash including urticaria, pruritus,
myalgia, dizziness, and diaphoresis.
If an infusion-related reaction occurs, consider slowing or
stopping the infusion and administer appropriate medications and/or
supportive care.
Clinical Worsening After Bamlanivimab
Administration
Clinical worsening after administration of bamlanivimab has been
reported and may include signs or symptoms of fever, hypoxia or
increased respiratory difficulty, arrhythmia (e.g., atrial
fibrillation, sinus tachycardia, bradycardia), fatigue, and altered
mental status. Some of these events required hospitalization. It is
not known if these events were related to bamlanivimab use or were
due to progression of COVID-19.
Limitations of Benefit and Potential Risk in Patients with
Severe COVID-19
Benefit of treatment with bamlanivimab
has not been observed in patients hospitalized due to COVID-19.
Monoclonal antibodies, such as bamlanivimab, may be associated with
worse clinical outcomes when administered to hospitalized patients
requiring high flow oxygen or mechanical ventilation with COVID-19.
See Limitations of Authorized Use.
Adverse Events
Adverse events reported in at
least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700
mg and placebo were Nausea (3% vs 4%), Diarrhea (1% vs 5%),
Dizziness (3% vs 2%), Headache (3% vs 2%), Pruritus (2% vs 1%) and
Vomiting (1% vs 3%).
Use in Specific
Populations
Pregnancy
There are
insufficient data on the use of bamlanivimab during pregnancy.
Bamlanivimab should only be used during pregnancy if the potential
benefit outweighs the potential risk for the mother and the
fetus.
Breastfeeding
There are no available data on
the presence of bamlanivimab in human or animal milk, the effects
on the breastfed infant, or the effects on milk production.
Breastfeeding individuals with COVID-19 should follow practices
according to clinical guidelines to avoid exposing the infant to
COVID-19.
About BLAZE-4
BLAZE-4 (NCT04634409) is a randomized,
double-blind, placebo-controlled trial designed to assess the
efficacy and safety of bamlanivimab alone, and bamlanivimab with
other neutralizing antibodies including VIR-7831 (GSK4182136)
versus placebo for the treatment of symptomatic low-risk COVID-19
in the outpatient setting. Across all treatment arms, the trial
will enroll an estimated 1,000 participants in the United States and Puerto Rico.
The primary outcome measure is percentage of participants who
have a viral load greater than 5.27 at day 7. Additional endpoints
include viral load change from baseline to day 7 in SARS-CoV-2
viral load, percentage of participants who experience COVID-related
hospitalization, ER visit or death from baseline through day 29, as
well as safety.
About COMET-ICE
COMET-ICE is a multi-center,
double-blind, placebo-controlled Phase 3 trial evaluating VIR-7831
in adults with mild or moderate COVID-19 at high risk of
progression to severe disease. The trial was stopped for enrollment
on March 10, 2021, based on an
interim analysis, which demonstrated an 85% (p=0.002) reduction in
hospitalization or death in those receiving VIR-7831 compared to
placebo.
About bamlanivimab
Bamlanivimab is a
recombinant, neutralizing human IgG1 monoclonal antibody (mAb)
directed against the spike protein of SARS-CoV-2. It is designed to
block viral attachment and entry into human cells, thus
neutralizing the virus, potentially treating COVID-19. Bamlanivimab
emerged from the collaboration between Lilly and AbCellera to
create antibody therapies for the prevention and treatment of
COVID-19. Lilly scientists rapidly developed the antibody in less
than three months after it was discovered by AbCellera and the
scientists at the National Institute of Allergy and Infectious
Diseases (NIAID) Vaccine Research Center. It was identified from a
blood sample taken from one of the first U.S. patients who
recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab
in hospitalized patients with COVID-19 (NCT04411628). A Phase
2/3 study in people recently diagnosed with COVID-19 in the
ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3
study of bamlanivimab for the prevention of COVID-19 in residents
and staff at long-term care facilities (BLAZE-2, NCT04497987) is
ongoing. In addition, bamlanivimab is being tested in the National
Institutes of Health-led ACTIV-2 study in ambulatory COVID-19
patients.
Bamlanivimab is authorized in the U.S. for the treatment of mild
to moderate COVID-19 in adults and pediatric patients 12 years and
older with a positive COVID-19 test, who are at high risk for
progressing to severe COVID-19 and/or hospitalization. Bamlanivimab
should be administered as soon as possible after a positive
COVID-19 test and within 10 days of symptom onset.
About VIR-7831 / GSK4182136
VIR-7831 is an
investigational dual-action SARS-CoV-2 monoclonal antibody.
Preclinical data suggest it has the potential to both block viral
entry into healthy cells and clear infected cells. The antibody
binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1
(the virus that causes SARS), indicating that the epitope is highly
conserved, which may make it more difficult for resistance to
develop. VIR-7831, which incorporates Xencor's Xtend™ technology,
also has been designed to achieve high concentration in the lungs
to ensure optimal penetration into airway tissues affected by
SARS-CoV-2 and to have an extended half-life.
About the Vir and GSK Coronavirus Collaboration
In
April 2020, Vir and GSK entered into
a collaboration to research and develop solutions for
coronaviruses, including SARS-CoV-2, the virus that causes
COVID-19. The collaboration uses Vir's proprietary monoclonal
antibody platform technology to accelerate existing and identify
new anti-viral antibodies that could be used as therapeutic or
preventive options to help address the current COVID-19 pandemic
and future outbreaks. The companies will leverage GSK's expertise
in functional genomics and combine their capabilities in CRISPR
screening and artificial intelligence to identify anti-coronavirus
compounds that target cellular host genes. They will also apply
their combined expertise to research SARS-CoV-2 and other
coronavirus vaccines.
About Lilly's COVID-19 Efforts
Lilly is
bringing the full force of its scientific and medical expertise to
attack the coronavirus pandemic around the world. Existing Lilly
medicines are being studied to understand their potential in
treating complications of COVID-19, and the company is
collaborating with partner companies to discover novel antibody
treatments for COVID-19. Lilly is testing both single antibody
therapy as well as combinations of antibodies as potential
therapeutics for COVID-19. Visit Lilly's COVID-19 disease area
page for resources related to Lilly's COVID-19 efforts.
GSK Commitment to Tackling COVID-19
GSK's response to
COVID-19 has been one of the broadest in the industry, with three
potential treatments in addition to our vaccine candidates in
development.
GSK is collaborating with several organisations on COVID-19
vaccines by providing access to our adjuvant technology. In
addition to our work with Medicago, a collaboration with Sanofi on
an adjuvanted, protein-based vaccine candidate is now in Phase 2.
An earlier stage collaboration with SK Bioscience is also ongoing.
SK Bioscience receives funding from CEPI and the Bill and Melinda
Gates Foundation to develop differentiated, affordable COVID-19
vaccines for supply globally through the COVAX facility. The use of
an adjuvant can be of particular importance in a pandemic since it
may reduce the amount of vaccine protein required per dose,
allowing more vaccine doses to be produced and contributing to
protecting more people.
GSK is also working with mRNA specialist, CureVac, to jointly
develop next generation, multi-valent mRNA vaccines for COVID-19
with the potential to address multiple emerging variants in one
vaccine. GSK will also support manufacturing of up to 100m doses of CureVac's first generation COVID-19
vaccine.
GSK is also exploring potential therapeutic or treatment options
for COVID-19 patients. We are collaborating with Vir Biotechnology
to develop existing and identify new anti-viral antibodies that
could be used as therapeutic or preventive options for COVID-19. We
recently reported that an Independent Data Monitoring Committee
recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as
monotherapy for the early treatment of COVID-19 in adults at high
risk of hospitalization be stopped for enrolment due to evidence of
profound efficacy, based on an interim analysis of data from the
trial. We are seeking Emergency Use Authorization in the US and
authorizations in other countries. We are also assessing whether an
investigational monoclonal antibody, otilimab, can help severely
ill COVID-19 patients aged over 70 who experience an overreaction
of their immune system.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with
discovery to create medicines that make life better for people
around the world. We were founded more than a century ago by a man
committed to creating high-quality medicines that meet real needs,
and today we remain true to that mission in all our work. Across
the globe, Lilly employees work to discover and bring life-changing
medicines to those who need them, improve the understanding and
management of disease, and give back to communities through
philanthropy and volunteerism. To learn more about Lilly, please
visit us at www.lilly.com and www.lilly.com/news.
P-LLY
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 COVID-19, hepatitis B virus, influenza A and
human immunodeficiency virus. For more information, please
visit www.vir.bio.
About GSK
GSK is a science-led global healthcare
company with a special purpose: to help people do more, feel
better, live longer. For further information please visit
www.gsk.com/about-us.
Lilly Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking
statements (as that term is defined in the Private Securities
Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) as a
potential treatment for patients with or at risk of infection from
COVID-19, alone and in combination with other antibodies, including
VIR-7831, and Lilly's
development plans and collaboration efforts, and reflects Lilly's
current beliefs and expectations. However, as with any such
undertaking, there are substantial risks and uncertainties in the
process of drug research, development and commercialization and in
drug collaborations. Among other things, there can be no
guarantee that future study results will be consistent with
the results to date, that bamlanivimab alone or administered with
VIR-7831 or any other therapy will prove to be a safe and effective
treatment or preventative for COVID-19, that bamlanivimab alone or
administered with VIR-7831 or any other therapy will receive
regulatory approvals or additional authorizations, that patients
will volunteer to participate in a study of bamlanivimab alone or
administered with VIR-7831 or any other therapy or achieve
positive outcomes or that Lilly and its partners can provide an
adequate supply of bamlanivimab alone or administered with VIR-7831
or any other therapy in all circumstances. For a further
discussion of these and other risks and uncertainties that could
cause actual results to differ from Lilly's expectations, please
see Lilly's most recent Forms 10-K and 10-Q filed with the U.S.
Securities and Exchange Commission. Lilly undertakes no duty to
update 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
"may," "will," "plan," "potential," "aim," "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 the timing of availability of preclinical and
clinical data, clinical development program updates, and data
disclosures related to VIR-7831, the ability of VIR-7831 to treat
and/or prevent COVID-19 (as monotherapy and in combination with
bamlanivimab), the potential of VIR-7831 in the hospitalized
population, the ability of VIR-7831 to neutralize the SARS-CoV-2
live virus, the ability of VIR-7831 to maintain full activity
against variant strains of the virus, Vir's collaboration with GSK,
and statements related to regulatory authorizations and approvals,
including plans to continue discussions with the FDA, the EMA and
other global regulators. Many factors may cause differences between
current expectations and actual results, including challenges in
obtaining regulatory approval, unexpected safety or efficacy data
observed during preclinical or clinical studies, challenges in the
treatment of hospitalized patients, difficulties in collaborating
with other companies or government agencies, challenges in
accessing manufacturing capacity, successful development and/or
commercialization of alternative product candidates by our
competitors, changes in expected or existing competition, delays in
or disruptions to our business or clinical trials due to the
COVID-19 pandemic, geopolitical changes or other external factors,
and unexpected litigation or other disputes.
GSK Cautionary Statement Regarding Forward-Looking
Statements
GSK cautions investors that any forward-looking
statements or projections made by GSK, including those made in this
announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Such
factors include, but are not limited to, those described in the
Company's Annual Report on Form 20-F for 2020 and any impacts of
the COVID-19 pandemic.
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Contact:
Media, Vir
Cara
Miller
VP, Corporate Communications
cmiller@vir.bio
+1-415-941-6746
Investors, Lilly
Kevin
Hern
hern_kevin_r@lilly.com
+1-317-277-1838
Media, Lilly
Molly
McCully
mccully_molly@lilly.com
+1-317-478-5423
Media, Lilly
Dani
Barnhizer
dbarnhizer@lilly.com
+1-317-607-6119
Investors, GSK
Jeff
McLaughlin
jeffrey.r.mclaughlin@gsk.com
+1-215-751-7002
Media, GSK
Lyndsay
Meyer
lyndsay.m.meyer@gsk.com
+1-202-302-4595
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