GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc.
(Nasdaq: VIR) today announced final, confirmatory results from the
Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial –
Intent to Care Early) trial demonstrating that sotrovimab, an
investigational SARS-CoV-2 monoclonal antibody, significantly
reduced the risk of hospitalization or death among high-risk adult
outpatients with mild-to-moderate COVID-19. Additionally, the U.S.
National Institutes of Health (NIH) updated its COVID-19 treatment
guidelines to recommend sotrovimab for non-hospitalized patients
with mild-to-moderate COVID-19 who are at high risk of clinical
progression and noted that sotrovimab appears to retain activity
against current variants of concern and interest.
The primary efficacy analysis of all 1,057
patients in the COMET-ICE trial demonstrated a 79% reduction
(adjusted relative risk reduction) (p<0.001) in hospitalization
for more than 24 hours or death due to any cause, by Day 29
compared to placebo, meeting the primary endpoint of the trial.
The number of patients in the trial who were
hospitalized for >24 hours for acute management of any illness
or death from any cause at Day 29 was six patients in the
sotrovimab arm (1%), versus 30 patients in the placebo arm (6%). In
the sotrovimab arm, it is possible that half of those patients who
were hospitalized were for reasons other than progression of
COVID-19 (e.g., small bowel obstruction, lung cancer and diabetic
foot ulcer); this was not the case for patients in the placebo arm.
In the safety analysis, 1,037 participants were followed through at
least 29 days. The most common adverse events observed in the
sotrovimab treatment group in COMET-ICE were rash (1%) and diarrhea
(2%), all of which were Grade 1 (mild) or Grade 2 (moderate). No
other treatment-emergent adverse events were reported at a higher
rate with sotrovimab compared to placebo. The companies plan to
submit the full COMET-ICE data set to a peer-reviewed journal for
publication.
Christopher Corsico, senior vice
president of development, GSK, said: “Effective medicines
to treat those who become infected with SARS-CoV-2 remain a
critical part of the solution to this pandemic. We are working
diligently to increase access to sotrovimab in the U.S. and across
the globe, including evaluating the potential to simplify
administration with an intramuscular formulation.”
George Scangos, Ph.D., chief executive
officer of Vir, said: “We are pleased that the profound
interim efficacy from the COMET-ICE trial has now been validated by
the full study population. These results, combined with the growing
number of pending global authorizations, as well as the recent
recommendation by the NIH COVID-19 Treatment Guidelines Panel,
support our confidence in the potential role of sotrovimab in the
fight against this pandemic.”
Updated NIH Guidelines Recommend
SotrovimabThe NIH recently updated its guidelines
regarding the emergency use authorizations of anti-SARS-CoV-2
monoclonal antibodies for the treatment of COVID-19 in the U.S. to
recommend the use of sotrovimab for non-hospitalized patients with
mild-to-moderate COVID-19 who are at high risk of clinical
progression. The guidelines note that the target binding site of
sotrovimab is in a region of the virus that does not overlap with
the binding site location of key mutations in current variants of
concern and interest. These guidelines were based upon an interim
analysis of 583 patients in the COMET-ICE trial, which was stopped
early in March 2020 by an independent data monitoring committee
because interim results demonstrated evidence of sotrovimab’s
clinical efficacy. The interim study results demonstrated an 85%
(p=0.002) reduction in hospitalization for more than 24 hours or
death in those receiving sotrovimab compared to placebo, the
primary endpoint of the trial.
These data have informed global regulatory
reviews to date, including the positive scientific opinion issued
by the European Medicines Agency’s (EMA) Committee for Human
Medicinal Products (CHMP) under Article 5(3) of Regulation
726/2004, as well as the Emergency Use Authorization (EUA) granted
by the U.S. Food and Drug Administration (FDA).
The companies are actively working with
government agencies around the world to make sotrovimab available
to patients in need of treatment.
- GSK and Vir plan to submit a
Biologics License Application (BLA) to the U.S. FDA in the second
half of 2021.
- The EMA has started a rolling
review of data on sotrovimab that will continue until enough
evidence is available to support the filing of a formal marketing
authorization application.
- The companies’ strategic
manufacturing network is enabling the manufacture of approximately
two million doses to support emergency supply in the first year
following U.S. Emergency Use Authorization, with approximately
450,000 doses on hand.
Continued Progress with the COMET
Clinical Development ProgramThe companies are also pleased
to announce continued progress with the robust COMET clinical
development program, which aims to provide clinical evidence from
several studies over the course of the next year.
- COMET-PEAK, a pharmacokinetic study
in outpatients with mild-to-moderate COVID-19 investigating
intramuscular (IM) administration of sotrovimab, is near completion
and initial data is expected in second half of 2021.
- COMET-TAIL has been initiated. This
is a Phase 3 study evaluating the role of IM-administered
sotrovimab for the early treatment of mild-to-moderate COVID-19 in
high-risk non-hospitalized adult and pediatric patients (12 years
of age and older). Data are anticipated in the first half of
2022.
- A prophylaxis study is planned in
uninfected immunocompromised adults to determine whether
IM-administered sotrovimab can prevent symptomatic COVID-19
infection.
GSK and Vir are committed to ongoing evaluation
of sotrovimab as the COVID-19 landscape continues to evolve at
different rates across the globe and new variants of concern and
interest emerge. Data from in vitro studies, published in bioRxiv,
have demonstrated that sotrovimab maintains activity against
circulating variants of concern and interest, including the Gamma
(P.1), Epsilon (B.1.427/B.1.429), Delta (B.1.617.1), Iota
(B.1.526), Beta (B.1.351) and Alpha (B.1.1.7) variants. GSK and Vir
are continuing to evaluate the ability of sotrovimab to maintain
activity against new and emerging variants through in vitro
studies. The clinical impact of this in vitro variants data is not
yet known.
About Sotrovimab (previously
VIR-7831)Sotrovimab is an investigational 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. Sotrovimab, 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.
The following is a summary of information for
sotrovimab. Healthcare providers in the U.S. should review the Fact
Sheets for information on the authorized use of sotrovimab 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. For more
information on the EMA positive scientific opinion, please review
the EU Conditions of Use.
Important Information about
SotrovimabSotrovimab has been authorized by the FDA
for the emergency use described below. Sotrovimab is not
FDA-approved for this use.
Sotrovimab is authorized only for the
duration of the declaration that circumstances exist justifying the
authorization of the emergency use of sotrovimab under
section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner.
Authorized Use The U.S.
Food and Drug Administration (FDA) has issued an Emergency Use
Authorization (EUA) to permit the emergency use of the unapproved
product sotrovimab for the treatment of mild-to-moderate
coronavirus disease 2019 (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 progression to severe
COVID-19, including hospitalization or death.
Limitations of Authorized
Use Sotrovimab 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 sotrovimab has not
been observed in patients hospitalized due to COVID-19. SARS-CoV-2
monoclonal antibodies may be associated with worse clinical
outcomes when administered to hospitalized patients with COVID-19
requiring high flow oxygen or mechanical ventilation.
Important Safety Information for
Sotrovimab
Warnings
There are limited clinical data available for
sotrovimab. Serious and unexpected adverse events may occur that
have not been previously reported with sotrovimab use.
Hypersensitivity Including Anaphylaxis
and Infusion-Related Reactions
Serious hypersensitivity reactions, including
anaphylaxis have been observed with administration of sotrovimab.
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, occurring during the
infusion and up to 24 hours after the infusion, have been observed
with administration of sotrovimab. 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 (eg, 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, vaso-vagal reactions (eg,
pre-syncope, syncope), dizziness and diaphoresis.
Consider slowing or stopping the infusion and
administer appropriate medications and/or supportive care if an
infusion-related reaction occurs.
Hypersensitivity reactions occurring more than
24 hours after the infusion have also been reported with the use of
SARS-CoV-2 monoclonal antibodies under Emergency Use
Authorization.
Clinical Worsening After SARS-CoV-2
Monoclonal Antibody Administration
Clinical worsening of COVID-19 after
administration of SARS-CoV-2 monoclonal antibody treatment has been
reported and may include signs or symptoms of fever, hypoxia or
increased respiratory difficulty, arrhythmia (eg, atrial
fibrillation, tachycardia, bradycardia), fatigue, and altered
mental status. Some of these events required hospitalization. It is
not known if these events were related to SARS-CoV-2 monoclonal
antibody use or were due to progression of COVID-19.
Limitations of Benefit and Potential for
Risk in Patients with Severe COVID-19
Benefit of treatment with sotrovimab has not
been observed in patients hospitalized due to COVID-19. SARS-CoV-2
monoclonal antibodies may be associated with worse clinical
outcomes when administered to hospitalized patients with COVID-19
requiring high flow oxygen or mechanical ventilation. Therefore,
sotrovimab 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.
ADVERSE EVENTS
The most common treatment-emergent adverse
events observed in the sotrovimab treatment group in COMET-ICE were
rash (2%) and diarrhea (1%), all of which were Grade 1 (mild) or
Grade 2 (moderate). No other treatment-emergent adverse events were
reported at a higher rate with sotrovimab compared to placebo.
USE IN SPECIFIC POPULATIONS
Pregnancy
There are insufficient data to evaluate a
drug-associated risk of major birth defects, miscarriage, or
adverse maternal or fetal outcome. Sotrovimab should be used during
pregnancy only if the potential benefit justifies the potential
risk for the mother and the fetus.
Lactation
There are no available data on the presence of
sotrovimab in human milk, the effects on the breastfed infant, or
the effects on milk production. Individuals with COVID-19 who are
breastfeeding should follow practices according to clinical
guidelines to avoid exposing the infant to COVID-19.
About the Vir and GSK
CollaborationIn 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.
GSK Commitment to Tackling
COVID-19GSK’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 with partner
organizations.
GSK is collaborating with several organizations
on COVID-19 vaccines by providing access to our adjuvant
technology. In addition to our work with Medicago, we recently
announced positive Phase 2 data from our collaboration with Sanofi
to develop an adjuvanted, protein-based vaccine candidate and
expect to begin a Phase 3 trial in Q2. 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 providing manufacturing support for
up to 60m doses of Novavax’ COVID-19 vaccine in the UK.
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 reported that an Independent Data Monitoring
Committee recommended that the Phase 3 COMET-ICE trial
evaluating sotrovimab as monotherapy for the early
treatment of COVID-19 in adults at high risk of hospitalization be
stopped for enrollment due to evidence of profound efficacy, based
on an interim analysis of data from the trial. An analysis of data
through Day 29 of the COMET-ICE trial was consistent with interim
results. We have received Emergency Use Authorization in the U.S.
and are seeking 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.
Vir’s Commitment to COVID-19Vir
was founded with the mission of addressing the world’s most serious
infectious diseases. In 2020, Vir responded rapidly to the COVID-19
pandemic by leveraging our unique scientific insights and
industry-leading antibody platform to explore multiple monoclonal
antibodies as potential therapeutic or preventive options for
COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir
advanced into the clinic. It was carefully selected for its
demonstrated promise in preclinical research, including an
anticipated high barrier to resistance and potential ability to
both block the virus from entering healthy cells and clear infected
cells. Vir is continuing to pursue novel therapeutic and
prophylactic solutions to combat SARS-CoV-2 and future coronavirus
pandemics, both independently and in collaboration with its
partners.
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.
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.
GSK Cautionary Statement Regarding
Forward-Looking StatementsGSK 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.
Vir Forward-Looking
StatementsThis 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 final data from
the COMET-ICE trial, NIH guidelines recommending the use of
sotrovimab in the treatment of COVID-19, the initiation of Vir’s
COMET-TAIL clinical trial, the clinical development program for
sotrovimab, Vir’s capacity to manufacture and supply sotrovimab,
the ability of sotrovimab to treat and/or prevent COVID-19, the
ability of sotrovimab to maintain activity against circulating
variants of concern, and statements related to regulatory
authorizations and approvals, including plans and discussions with
the FDA, EMA and other global regulators. Many factors may cause
differences between current expectations and actual results,
including 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 Vir’s
competitors, 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.
Registered
in England & Wales:No. 3888792
Registered Office:980 Great
West RoadBrentford, MiddlesexTW8 9GS
Vir Biotechnology Contact:
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1 415 941 6746
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