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 October 2023
Commission
File Number 001-15170
GSK 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 . . . . . . . .
Issued: 25 October 2023, London UK
New data
for Arexvy, GSK's
RSV vaccine, show potential to help protect adults aged 50 to 59 at
increased risk for RSV disease
●
Preliminary
results from phase III trial show primary endpoints met, with
non-inferior immune responses observed in adults aged 50-59
compared to adults aged 60 and older
●
Adults aged 50 and above with
certain underlying medical conditions are at increased risk for RSV
disease1
●
GSK
is on track to be the first company to submit data in this
population to regulators, with decisions on potential label
expansion expected in 2024
GSK plc (LSE/NYSE: GSK) today announced positive preliminary
results from its phase III trial
[https://clinicaltrials.gov/study/NCT05590403] evaluating the
immune response and safety of Arexvy (respiratory syncytial virus vaccine,
adjuvanted) in adults aged 50 to 59, including those at increased
risk of respiratory syncytial virus (RSV) lower respiratory tract
disease (LRTD) due to certain underlying medical conditions. These
results will be presented at the US Centers for Disease Control and
Prevention's (CDC) Advisory Committee on Immunization Practices
(ACIP) meeting on 25 October 2023. This vaccine is currently
approved in the US for active immunisation for the prevention of
RSV-LRTD in adults 60 years of age and older. It
is also approved in Europe, Japan and several other
countries.
The vaccine elicited an immune response in adults aged 50 to 59 at
increased risk for RSV disease due to select underlying medical
conditions that was non-inferior to that observed in adults aged 60
and above, meeting the trial's primary co-endpoint. Vaccine
efficacy has previously been demonstrated in adults aged 60 and
above. The co-primary endpoint was also met for the broader group
of adults aged 50 to 59 also enrolled in the trial. Safety and
reactogenicity data were consistent with results from the initial
phase III programme. The most common local adverse event was pain,
and most common systematic adverse events were fatigue and
headache, most of which were transient and mild in
intensity.
Tony Wood, Chief Scientific Officer, GSK, said: "This
trial reinforces our confidence in our RSV vaccine's ability to
help protect adults aged 50 to 59 at increased risk for RSV-LRTD.
We will submit these data for regulatory review as quickly as
possible with the goal of offering adults in this age group the
option of a vaccine for the first time."
RSV is a common, contagious virus that can cause severe respiratory
illness.2 Estimated
rates of infection and hospitalisation may be higher than reported
in many high income countries, including the US.3 There
is a substantial burden of RSV-associated illness for adults at
increased risk for RSV disease due to advanced age,
immunocompromised status, or underlying medical conditions, such as
chronic obstructive pulmonary disease (COPD), asthma, and chronic
heart failure. RSV can exacerbate these conditions and lead to
pneumonia, hospitalisation, or death.4
Final results from this trial will be presented at an upcoming
medical conference and submitted for
peer-reviewed publication.
The data will also be submitted to the US Food and Drug
Administration (FDA) and other regulators to support potential
label expansions.
Trial design
NCT05590403 is a phase III, placebo-controlled, observer-blind,
randomized, multi-country immunogenicity trial to evaluate the
non-inferiority of the immune response and evaluate safety in
participants aged 50 to 59 at increased risk of RSV-LRTD compared
to older adults aged 60 years and above after a single dose of
GSK's RSV vaccine. Immune response in participants aged 50 to 59
with pre-defined stable chronic diseases leading to an increased
risk of RSV disease was assessed (n=570). These included
participants with chronic pulmonary disease, chronic cardiovascular
disease, diabetes, chronic kidney disease or chronic liver disease.
Immune responses in a broader group of participants aged 50 to 59
without these pre-defined chronic diseases (n=570) was also
evaluated compared to adults aged 60 and
older. Approximately
1,520 participants were enrolled across eight
countries.
The trial's primary endpoints were RSV-A and RSV-B neutralisation
titres of both groups of 50 to 59 year olds at one month after the
vaccine administration compared to adults aged 60 and older. There
were also safety and immunogenicity secondary and tertiary
endpoints. The trial is ongoing to collect further immune data at
six months and 12 months after vaccine administration.
About Arexvy (respiratory syncytial virus vaccine,
adjuvanted)
Respiratory syncytial virus vaccine, adjuvanted, contains
recombinant glycoprotein F stabilised in the prefusion conformation
(RSVPreF3). This antigen is combined with GSK's proprietary
AS01E adjuvant.
The vaccine was approved by the US FDA on 3 May 2023 for the
prevention of LRTD caused by RSV in individuals 60 years of age and
older.
In June 2023, the European Commission authorised the vaccine for
active immunisation for the prevention of LRTD caused by RSV in
adults aged 60 years and older.
In September 2023, Japan's Ministry of Health, Labour and Welfare
approved the vaccine for the prevention of RSV disease for adults
aged 60 years and above.
The vaccine has also been approved in the UK and Canada. Regulatory
reviews in other countries are ongoing. The proposed trade name
remains subject to regulatory approval in other
markets.
The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON
adjuvant licensed from Antigenics Inc., a wholly owned subsidiary
of Agenus Inc.
Please see the full US Prescribing Information:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF
About RSV in adults
RSV is a common contagious virus affecting the lungs and breathing
passages.2 Adults
can be at increased risk for RSV disease due to comorbidities,
immune compromised status, or advanced age.4 RSV
can exacerbate conditions, including COPD, asthma, and chronic
heart failure and can lead to severe outcomes, such as pneumonia,
hospitalisation, and death.4 Each
year, approximately 177,000 adults 65 years and older are
hospitalised in the US due to RSV; an estimated 14,000 cases result
in death.5 For
adults 60 and older, data suggest an increased risk for severe RSV
infection that can lead to hospitalisation.6,7
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.
GSK enquiries
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Media:
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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Simon Moore
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+44 (0) 20 8047 5502
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(London)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Alison Hunt
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+1 540 742 3391
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(Washington DC)
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Investor Relations:
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Nick Stone
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+44 (0) 7717 618834
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mick Readey
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+44 (0) 7990 339653
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(London)
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Josh Williams
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+44 (0) 7385 415719
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(London)
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Camilla Campbell
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+44 (0) 7803 050238
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(London)
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Steph Mountifield
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+44 (0) 7796 707505
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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
2022, and Q2 Results for 2023 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1.
Branche et al. Incidence of Respiratory Syncytial
Virus Infection Among Hospitalized Adults,
2017-2020. Clin Infect
Dis 2022:74:1004-1011.
2.
National Foundation for Infectious Diseases.
Respiratory Syncytial Virus. Accessed October 2023. Available
at: www.nfid.org/infectious-disease/rsv/
3.
Savic
M, Penders Y, Shi T, Branche A, Pirçon J-Y. Respiratory
syncytial virus disease burden in adults aged 60 years and older in
high-income countries: a systematic literature review and
meta-analysis. Influenza Other Respir Viruses 2022 2023;
17:e13031.
4.
Centers for Disease Control and Prevention. RSV in
Older Adults and Adults with Chronic Medical Conditions. Accessed
October 2023. Available at: www.cdc.gov/rsv/high-risk/older-adults.html
5.
Falsey AR, et al. N
Engl J Med 2005; 352:1749-1759 DOI: 10.1056/NEJMoa043951. Accessed
October 2023.
6.
Tseng HF, Sy LS,
Ackerson B, et al. Severe morbidity and short- and mid- to
long-term mortality in older adults hospitalized with respiratory
syncytial virus infection. J Infect Dis. 2020;222(8):1298-1310.
doi:10.1093/infdis/jiaa361.
7.
Belongia EA, King
JP, Kieke BA, et al. Clinical features, severity, and incidence of
RSV illness during 12 consecutive seasons in a community cohort of
adults ≥60 years old. Open Forum Infect Dis.
2018;5(12):ofy316. doi:10.1093/ofid/ofy316.
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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GSK plc
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(Registrant)
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Date: October
25, 2023
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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 GSK plc
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