REG - GSK PLC - NEJM publishes GSK RSV OA vaccine candidate trial

GSKAnnouncement

16/02/2023 07:01

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RNS Number : 0791Q  GSK PLC  15 February 2023

Issued: 15 February 2023, London UK

 

Landmark New England Journal of Medicine publication reinforces potential of
GSK's respiratory syncytial virus older adult vaccine candidate

 

·   First peer-reviewed publication of phase III respiratory syncytial
virus vaccine data in older adults, including those with comorbidities who are
most at risk

·   Expert perspective recognises a new era in vaccine design based on
progress in respiratory syncytial virus research

·   Vaccine on track to become available in 2023 pending regulatory
decisions in the US, EU, and other countries

 

GSK plc (LSE/NYSE: GSK) today announced the publication of positive phase III
trial results for its respiratory syncytial virus (RSV) older adult vaccine
candidate in the New England Journal of Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa2209604) . The publication
summarises the pivotal efficacy data (previously presented
(https://www.gsk.com/en-gb/media/press-releases/gsk-s-older-adult-respiratory-syncytial-virus-rsv-vaccine-candidate/)
at IDWeek 2022), showing the vaccine candidate met the primary endpoint of
vaccine efficacy against RSV-lower respiratory tract disease (LRTD) in adults
aged 60 years and above, with a favourable safety profile. In addition,
positive vaccine efficacy was observed in participants with comorbidities of
interest who are at increased risk of severe outcomes.

 

RSV is one of the major infectious diseases without a vaccine or specific
treatment available for older adults. The accompanying New England Journal of
Medicine expert perspective article recognises the significant progress that
has been made in RSV vaccine design. GSK is the first company to publish
positive peer-reviewed phase III data for an RSV older adult vaccine
candidate.

 

Tony Wood, Chief Scientific Officer, GSK, said: "Our ambition is to protect
the many older adults at risk from RSV disease, including those with
underlying health conditions, who account for the majority of severe RSV
outcomes. We are delighted to publish these exceptional data in the New
England Journal of Medicine. We look forward to making the vaccine available
as quickly as possible, pending regulatory decisions, and sharing more data
from our ongoing clinical development programme as we work to get ahead of
this potentially debilitating virus."

 

Professor Martinón-Torres, Co-ordinator of the Vaccine Clinical Trials Unit,
Instituto de Investigación Sanitaria de Santiago, Spain, and one of the
authors on the New England Journal of Medicine publication, added: "Although
RSV often results in mild symptoms, it can have devastating consequences for
older adults and has a global burden that can approach that of seasonal
influenza. The publication of these important data shows that, for the first
time, we are on the cusp of having an effective vaccine that could
meaningfully impact public health."

 

GSK is on track to supply the vaccine candidate ahead of the 2023-24 northern
hemisphere RSV season, pending regulatory decisions in the US, EU, Japan, and
other countries. A meeting of the US Food and Drug Administration's Vaccines
and Related Biological Products Advisory Committee (VRBPAC) to review the
Biologics License Application will take place on 1 March 2023. There are
currently no RSV vaccines approved anywhere in the world.

 

RSV clinical development programme

GSK is conducting three additional phase III clinical trials that aim to
expand the population who may benefit from RSV vaccination into adults aged
50-59 with underlying comorbidities and to provide further evidence on
co-administration with other older adult vaccines.

 

These are fully recruited, and results are expected in 2023, together with
additional data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase
III efficacy trial and the AReSVi-004 immunogenicity trial. These continue to
evaluate an annual revaccination schedule and protection/immunogenicity over
multiple seasons following one dose of the RSV vaccine candidate.

 

·      NCT05590403
(https://clinicaltrials.gov/ct2/show/NCT05590403?term=NCT05590403&draw=2&rank=1)
will evaluate the immunogenicity and safety of the vaccine candidate in adults
50-59 years of age, including adults at increased risk of RSV-LRTD, compared
to its immunogenicity and safety in adults ≥60 years of age.

·      NCT05568797
(https://clinicaltrials.gov/ct2/results?cond=&term=NCT05568797&cntry=&state=&city=&dist=)
and NCT05559476
(https://clinicaltrials.gov/ct2/show/NCT05559476?term=NCT05559476&draw=2&rank=1)
will evaluate the vaccine candidate's immunogenicity, safety and
reactogenicity when co-administered with adjuvanted and high-dose influenza
vaccines in adults aged 65 years and above. These trials build on positive
data on the concomitant administration of GSK's RSV older adult vaccine
candidate with seasonal quadrivalent influenza vaccination presented at IDWeek
2022.

 

About GSK's RSV older adult vaccine candidate

GSK's RSV older adult vaccine candidate contains a recombinant subunit
prefusion RSV F glycoprotein antigen (RSVPreF3) combined with the Company's
proprietary AS01(E) adjuvant. Across multiple trials, the vaccine candidate
was generally well tolerated with a favourable safety profile. The most
frequently observed solicited adverse events were injection site pain,
fatigue, myalgia, and headache. These were typically mild to moderate and
transient. The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON
adjuvant licensed from Antigenics Inc, a wholly-owned subsidiary of Agenus
Inc.

 

About RSV in adults

RSV is a common contagious virus affecting the lungs and breathing passages.
It is one of the major remaining infectious diseases for which there is
currently no vaccine or specific treatment available for adults. Older adults
are at high risk for severe disease due in part to age-related decline in
immunity, and older adults with underlying conditions are at even greater risk
for severe disease. RSV can exacerbate conditions, including chronic
obstructive pulmonary disease, asthma and chronic heart failure and can lead
to severe outcomes, such as pneumonia, hospitalisation, and death. Each year
RSV causes over 470,000 hospitalisations and 33,000 deaths in adults in
high-income countries.(1) Adults with underlying conditions are more likely to
seek medical services and have higher hospitalisation rates than adults
without these conditions.

 

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
(https://www.gsk.com/en-gb/company/) .

 

 GSK enquiries
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                      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 in
the Company's Annual Report on Form 20-F for 2021, GSK's Q4 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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Registered Office:

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References

1.     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 November 11 (Epub ahead of print). [PMID:
36369772]. Accessed 6 December 2022. Available at: Respiratory syncytial virus
disease burden in adults aged 60 years and older in high
(https://onlinelibrary.wiley.com/doi/10.1111/irv.13031) ‐
(https://onlinelibrary.wiley.com/doi/10.1111/irv.13031) income countries: A
systematic literature review and meta
(https://onlinelibrary.wiley.com/doi/10.1111/irv.13031) ‐
(https://onlinelibrary.wiley.com/doi/10.1111/irv.13031) analysis - Savic -
Influenza and Other Respiratory Viruses - Wiley Online Library
(https://onlinelibrary.wiley.com/doi/10.1111/irv.13031)

 

 

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