TIDMGSK
RNS Number : 8287S
GSK PLC
14 March 2023
Issued: 14 March 2023, London UK
GSK announces positive pivotal phase III data for 5-in-1
Meningococcal ABCWY vaccine candidate
-- MenABCWY combination vaccine candidate met all 11 primary
endpoints of the pivotal phase III clinical trial and was well
tolerated with a safety profile consistent with Bexsero and
Menveo
-- The primary endpoint data demonstrated statistical
non-inferiority compared to Bexsero and Menveo in individuals 10-25
years old, with the 5-in-1 vaccine candidate eliciting a clinically
meaningful immune response
-- If approved, this 5-in-1 vaccine candidate could provide the
broadest meningococcal serogroup coverage and could lead to a
simplified immunisation schedule
GSK plc (LSE/NYSE: GSK) today announced positive headline
results from the phase III trial ( NCT04502693 ) evaluating the
safety, tolerability, and immunogenicity of its MenABCWY
combination vaccine candidate, administered as two doses given six
months apart in healthy individuals aged 10-25 years. GSK's
MenABCWY vaccine candidate combines the antigenic components of its
licensed meningococcal vaccines, Bexsero (MenB) and Menveo
(MenACWY). All primary endpoints were met, including the
non-inferiority of the vaccine candidate for all five Neisseria
meningitides serogroups (A, B, C, W, and Y) compared to licensed
meningococcal vaccines Bexsero and Menveo in terms of an immune
response. In addition, the vaccine candidate was well tolerated,
with a safety profile consistent with Bexsero and Menveo.
Invasive meningococcal disease (IMD), a major cause of
meningitis and septicaemia , is an uncommon but serious illness
that can cause life-threatening complications or even death,
typically amongst previously healthy children and adolescents.(1)
Among those contracting meningococcal diseases, one in ten will
die, sometimes in as little as 24 hours, despite treatment.(2)
One-in-five survivors suffers long-term consequences, such as brain
damage, amputations, hearing loss and nervous system problem
s.(1)
Five Neisseria meningitides serogroups (A, B, C, W, and Y)
account for nearly all IMD cases in most of the world.(3) As yet,
no licensed combination vaccine offers protection against these
serogroups in a single vaccine. Currently, in the US, two separate
vaccines needing four injections are required to protect against
all five serogroups. This immunisation regimen, coupled with low
awareness of the disease, can lead to sub-optimal immunisation
coverage rates, particularly for MenB, with an estimated coverage
of only approximately 31% of adolescents in the US.(4)
Tony Wood, Chief Scientific Officer at GSK, said : "These
statistically significant phase III data are a very encouraging
step toward reducing the incidence of meningococcal disease. In the
US, routine use of a 5-in-1 meningococcal vaccine with a two-dose
regimen in adolescents at 16 to 18 years of age, just before this
disease's incidence peak, could drive significant public health
impact. In addition, our 5-in-1 meningococcal vaccine candidate
builds on our global leadership in meningococcal vaccines and
commitment to innovation."
GSK is working closely with regulators to review the full phase
III data set, including the supplemental Biologics License
Application for Bexsero. This clinical trial was both the
confirmatory trial for Bexsero and the phase III trial for
MenABCWY. Detailed results from this phase III trial will be
presented in a peer-reviewed publication and at upcoming scientific
meetings.
About the MenABCWY phase III trial
The trial conducted by GSK is a phase III randomised,
controlled, observer-blind, multi-country trial to evaluate the
safety, tolerability, and immunogenicity of GSK's MenABCWY vaccine
candidate . It is part of a comprehensive programme to generate
clinical evidence on the benefits of meningococcal immunisation .
The trial started in August 2020, and approximately 3,650
participants aged 10-25 were enrolled in the US, Canada, Czech
Republic, Estonia, Finland, Turkey, and Australia.
The objective of the trial was to assess the safety profile of
the MenABCWY vaccine candidate and to compare the immune responses
of the trial's participants who received two doses of the MenABCWY
vaccine candidate six months apart to the responses of those in the
control groups who received GSK's licensed vaccines, Bexsero (MenB)
and Menveo (MenACWY).
About Bexsero
Bexsero is currently licensed or has received regulatory
approval in over 50 countries, including the US and EU, and is used
in 12 national immunisation programmes worldwide for the prevention
of IMD caused by Neisseria meningitides serogroup B. Bexsero is the
only MenB vaccine with trials that have demonstrated a reduction in
IMD, including vaccine effectiveness in real-world settings.
Regulatory approvals vary by country. It is approved for
individuals two months of age and older in Europe.
In the US, Bexsero is licensed under the Accelerated Approval
pathway for active immunisation to prevent IMD caused by Neisseria
meningitides serogroup B in individuals from 10 through 25 years.
Approval of Bexsero is based on demonstrating an immune response,
as measured by serum bactericidal activity against three serogroup
B strains representative of prevalent strains in the US. The
effectiveness of Bexsero against diverse serogroup B strains has
not been confirmed. The US Prescribing Information is available
here.
About Menveo
Menveo vaccine for meningococcal groups A, C, Y, and W has
received regulatory approval in over 60 countries, including the
US, with more than 72 million doses distributed worldwide since
2010. Menveo offers extensive evidence of immunogenicity with a
well-characterised safety profile (consistent with similar
vaccines).
In the US, Menveo has received regulatory approval for active
immunisation to prevent IMD caused by Neisseria meningitides
serogroups A, C, Y, and W in individuals from 2 months through 55
years of age. However, Menveo does not prevent N. meningitides
serogroup B infections. The US Prescribing Information is available
here.
About GSK
GSK is a global biopharma company with a purpose to unite
science, technology, and talent to get ahead of disease together.
Find out more at gsk.com/company
GSK enquiries
Media: Tim Foley +44 (0) 20 8047 (London)
5502
Simon Moore +44 (0) 20 8047 (London)
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Kathleen Quinn +1 202 603 5003 (Washington DC)
Alison Hunt +1 540 742 3391 (Washington DC)
Investor Relations: Nick Stone +44 (0) 7717 618834 (London)
James Dodwell +44 (0) 20 8047 (London)
2406
Mick Readey +44 (0) 7990 339653 (London)
Josh Williams +44 (0) 7385 415719 (London)
Camilla Campbell +44 (0) 7803 050238 (London)
Steph Mountifield +44 (0) 7796 707505 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
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
2022, GSK's Q4 Results for 2022 and any impacts of the COVID-19
pandemic.
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References
1 ECDC, Factsheet about meningococcal diseases . Accessed March
2023.
2. Bing Wang et al., "Case fatality rates of invasive
meningococcal disease by serogroup and age: A systematic review and
meta-analysis", in Vaccine, Volume 37, Issue 21, 9 May 2019, Pages
2768-2782. Accessed March 2023.
3 CDC. Meningococcal Disease Causes and How It Spreads | CDC .
Accessed March 2023.
4 Pingali C, Yankey D, Elam-Evans LD, et al. National
Vaccination Coverage Among Adolescents Aged 13-17 Years - National
Immunization Survey-Teen, United States, 2021. MMWR Morb Mortal
Wkly Rep 2022; 71:1101-1108.
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