UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of February 2021
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 25 February 2021, London UK
GSK announces results evaluating its investigational monoclonal
antibody, otilimab, for the treatment of hospitalised adult
patients with COVID-19
GlaxoSmithKline plc (LSE/NYSE:
GSK) today announced results
from the phase 2 proof of concept OSCAR
(Otilimab in Severe COVID-19 Related Disease) study
with otilimab, an investigational anti-granulocyte macrophage
colony-stimulating factor (anti-GM-CSF) monoclonal
antibody.
The primary endpoint of the OSCAR study was the proportion of
COVID-19 patients who were alive and free of respiratory failure 28
days after treatment with a single dose of otilimab in addition to
standard of care (including anti-viral treatments and
corticosteroids), compared to patients being treated with
standard of care alone. Data from patients of all ages showed a
treatment difference of 5.3% (95% CI= -0.8%, 11.4%) but this did
not reach statistical significance. However, a pre-planned
efficacy analysis by age in patients 70 years and older (N=180, 806
in total study) showed that 65.1% of patients were alive and free
of respiratory failure 28 days after treatment with otilimab plus
standard of care, compared to 45.9% of patients who received the
standard of care alone (delta of 19.1%, 95% CI=5.2%,
33.1%) (nominal p-value=0.009). In addition, in a mortality
analysis up to day 60, a treatment difference of 14.4% favouring
otilimab was seen with rates of 40.4% on standard of care vs. 26%
on otilimab plus standard of care (95% CI= 0.9%, 27.9%)
(nominal p-value=0.040) in patients 70 years and
older.
Given these data suggest a potentially important clinical benefit
in a pre-defined sub-group of high-risk patients and the public
health need, GSK has decided to amend the OSCAR study to expand
this cohort to confirm these potentially significant
findings.
Christopher Corsico, Senior Vice President
Development, GSK, said: "Patients
aged 70 and over account for 70% of COVID-related deaths and nearly
40% of hospitalisations. Our scientific understanding of COVID
continues to evolve at a rapid pace with recent studies suggesting
that GM-CSF is elevated in this group of patients. Given the
profound impact this pandemic is having on the elderly and the
encouraging data we are sharing today, we are hopeful this
finding will be replicated in the additional
cohort."
Approximately 10-15% of patients diagnosed with
COVID-19 experience severe disease involving
respiratory problems that can require hospitalisation
and intensive care, with an additional 5% of patients
becoming critically ill. Age is widely recognised as a
significant risk factor for severe COVID-19 disease. Greater
disease severity and increased mortality are consistently
observed in older patients with severe pulmonary COVID-19.
According to the United States' Centers for Disease Control
and Prevention, the risk
of hospitalisation is 5-times greater for patients age 70
to 74, rising to 8-times higher for patients age 75 and
older. These patients often need breathing
interventions including significant oxygen support or
mechanical ventilation. The severe respiratory
symptoms of COVID-19 are caused by the body's immune system going
into overdrive to eliminate the virus and can lead to
life-threatening complications or even death.
Recent research suggests the role of the cytokine GM-CSF
in the immune response to COVID-19 may be more prominent in
patients over the age of 70[1],
putting them at an increased risk for serious complications related
to COVID-19. There is an unmet need for additional
therapeutics to help mediate the immune response in this patient
population.
The additional cohort of the OSCAR study will follow a similar
study design and will enrol approximately 350 patients aged 70
years and older.
Currently available therapies have limited clinical benefit in the
more severe stages of hospitalised COVID-19 when patients require
high-flow oxygen or invasive mechanical ventilation. To date, no
targeted immunomodulatory therapy has been proven to have
sufficient benefit in improving recovery from respiratory failure
or reducing mortality in patients aged 70 years and
older.
In the OSCAR study, the most common serious adverse event observed
was respiratory failure (5% for placebo, 4% for otilimab). Overall,
all adverse events and serious adverse events observed were typical
for a severe COVID-19 population. In the 70 years and older
sub-group, the incidence rates of SAEs and fatal SAEs were lower in
the otilimab group compared with the placebo group.
About the Phase 2 OSCAR study
This global,
randomised, double-blind, placebo-controlled, multi-centre, proof-of-concept
phase 2a OSCAR study (NCT04376684) assessed
the efficacy and safety of a single intravenous infusion
of otilimab 90 mg given over an hour or placebo in
addition to standard of care in 806 hospitalised adults (ages 18 to
79 years) with severe COVID-19 related pulmonary disease.
Standard of care permitted the use of corticosteroids (including
dexamethasone), remdesivir, and convalescent plasma according to
local hospital/institutional policies. Study participants were
enrolled at 130 sites around the world, including in the United
States, Europe, Asia, Russia, South Africa and South America.
All participants had a positive SARS-CoV-2 test
result; been hospitalised due to a diagnosis of
pneumonia; had new onset of oxygenation impairment requiring
high-flow oxygen, non-invasive ventilation or mechanical
ventilation <48
hours before dosing; and had increased biological markers of
systemic inflammation.
Participants were considered 'alive and free of respiratory
failure' if they were off significant oxygen support measured using
a GlaxoSmithKline (GSK) modified version ordinal scale adapted from
World Health Organization (WHO) scale 2020.
A full analysis is ongoing and will be made available in an
upcoming pre-print publication when available.
About Otilimab
Otilimab (previously GSK3196165) is a fully human monoclonal
antibody that inhibits granulocyte-macrophage colony-stimulating
factor (GM-CSF), a protein that plays a central role in a broad
range of immune-mediated diseases, including rheumatoid arthritis.
GM-CSF acts on cells, including macrophages (an immune cell type
that plays a key role in the inflammatory process), leading to
inflammation, joint damage and pain. Otilimab neutralises the
biological function of GM-CSF by blocking the interaction of GM-CSF
with its cell surface receptor. In 2013 GSK assumed exclusive
worldwide responsibility of otilimab from MorphoSys AG for all
development and commercialisation activities in all therapeutic
fields.
GSK commitment to tackling COVID-19
GSK's response to COVID-19 has been one of the broadest in the
industry, with two 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 work with Sanofi, our collaboration with Medicago on an
adjuvanted, protein-based vaccine candidate is now in late-stage
clinical trials. An earlier stage collaboration with SK Bioscience
is also ongoing, with funding from CEPI and 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, 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, if
approved.
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.
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.
GSK enquiries:
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Media
enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Kristen
Neese
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+1 804
217 8147
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(Philadelphia)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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Sonya
Ghobrial
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+44 (0)
7392 784784
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(Consumer)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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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 under Item 3.D
"Risk Factors" in the company's Annual Report on Form 20-F for 2019
and any impacts of the COVID-19 pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980 Great West
Road
Brentford,
Middlesex
TW8
9GS
1 Thwaites et al. Elevated antiviral, myeloid and endothelial
inflammatory markers in severe COVID-19. 13 October 2020;
medRxiv preprint https://doi.org/10.1101/2020.10.08.20209411
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: February
25, 2021
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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