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 September 2024
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: 06 September 2024, London UK
GSK announces positive results from
phase III trial of Nucala (mepolizumab) in COPD
●
Primary
endpoint met with a statistically significant and clinically
meaningful reduction in annualised rate of moderate/severe
exacerbations vs. placebo with data up to two years
GSK plc (LSE/NYSE: GSK) today announced positive headline results
of MATINEE, the phase III clinical trial
evaluating Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5
(IL-5) in adults with
chronic obstructive pulmonary disease (COPD).
The trial recruited COPD patients with broad clinical presentations
of chronic bronchitis and/or emphysema, who were receiving
optimised inhaled maintenance therapy. Participants were also
required to have evidence of type 2 inflammation characterised by
raised blood eosinophil count.1 MATINEE
met its primary
endpoint with the addition of Nucala to
inhaled maintenance therapy, and study results showed
a statistically
significant and clinically meaningful reduction in the annualised
rate of moderate/severe exacerbations versus
placebo with patients treated for
up to 104 weeks.
The preliminary safety
results are consistent with the known safety profile
of Nucala.
Further analysis
of these data is ongoing.
COPD affects more than 300 million people globally with up to 40%
of patients exhibiting type 2 inflammation characterised by raised
blood eosinophil count, that drives
exacerbations.3,4 IL-5
is a key messenger protein (cytokine) in type 2
inflammation.5 Recurrent
exacerbations lead to damage
to the lungs, progressive lung function decline and risk of
hospitalisation. This can result in a vicious
cycle of deterioration in overall physical health, which leads to
worsening of symptoms and
quality of life, and increased mortality.6,7
The full results of MATINEE will be presented at a future
scientific congress and will inform ongoing discussions with
regulatory authorities. Nucala is currently not indicated for COPD anywhere
in the world.
About the mepolizumab development programme for COPD
The mepolizumab program in COPD is comprised of three clinical
trials. The first two studies, METREX and METREO, completed in
2017. MATINEE was designed to supplement METREX and METREO,
building on our learnings from these studies and IL-5 science to
identify the patients who could benefit the most
from Nucala and support future submissions and approvals
for use in this indication.3
MATINEE is a multi-centre, randomised, placebo controlled,
double-blind, parallel group study. The trial is designed to
confirm the benefits of mepolizumab treatment on moderate or severe
exacerbations in 806 COPD participants who were randomised to
receive mepolizumab, or a placebo, as an add on to their optimised
maintenance COPD therapy for at least 52 weeks and up to a maximum
of 104 weeks.1
About Nucala
First approved in 2015 for severe asthma with an eosinophilic
phenotype in the US, mepolizumab
is a monoclonal antibody that targets and binds to interleukin-5
(IL-5), a key messenger protein (cytokine) in type 2
inflammation. Nucala has
been developed for the treatment of a range of IL-5 mediated
diseases associated with type 2 inflammation.
For product and important safety information please consult the
country relevant summary of product characteristics.
EU and UK available at: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf
About chronic obstructive pulmonary disease (COPD)
COPD is the third leading cause of death worldwide with
exacerbations accounting for the greatest proportion of the total
COPD burden on the healthcare system.2, Patients
with COPD have chronic inflammation leading to persistent
respiratory symptoms such as breathlessness and a productive cough.
The daily impact on patients' lives can lead to anxiety and
depression.6 Exacerbations
are acute episodes of worsening COPD symptoms and can result in
hospitalisation, irreversible and cumulative lung damage or
death.6 Many
patients continue to experience exacerbations despite standard
treatment meaning that there is a need for targeted therapies that
address the underlying pathobiology.6,10,11 Up
to 40% of patients have evidence of type 2 inflammation that drives
exacerbations.3,4 Blood
eosinophil count is a biomarker for type 2 inflammation that can be
easily measured by a simple blood test and indicates a patient's
risk of exacerbation and deterioration, and response to treatment
in COPD.6 IL-5
is a core cytokine in type 2 inflammation. It is a major protein
responsible for the growth, maturation, activation and survival of
eosinophils, a type of white blood cell implicated in the
pathogenesis of type 2 inflammatory diseases. Evidence
indicates that IL-5 has an impact on other cell types beyond
eosinophils, including those that contribute to inflammation, lung
remodelling and disease progression.12-16
About GSK in respiratory
GSK continues to build on decades of pioneering work to deliver
more ambitious treatment goals, develop the next generation
standard of care, and redefine the future of respiratory medicine
for hundreds of millions of people with respiratory diseases. With
an industry-leading respiratory portfolio and pipeline of vaccines,
targeted biologics and inhaled medicines, we are focused on
improving outcomes and the lives of people living with all types of
asthma and COPD along with less understood refractory chronic cough
or rarer conditions like systemic sclerosis with interstitial lung
disease. GSK is harnessing the latest science and technology with
the aim to modify underlying disease dysfunction and prevent
disease progression.
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.
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GSK enquiries
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Media:
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Tim
Foley
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+44 (0)
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(London)
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Sarah
Clements
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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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Lyndsay
Meyer
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+1 202
302 4595
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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 GSK's Annual Report on Form 20-F for 2023, and
GSK's Q2 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1.
ClinicalTrials.gov. Mepolizumab as Add-on Treatment IN
Participants With COPD Characterized by Frequent Exacerbations and
Eosinophil Level (MATINEE) Available at: https://clinicaltrials.gov/study/NCT04133909
Last accessed July 2024.
2. GBD 2019 Chronic Respiratory
Diseases Collaborators. Global burden of chronic respiratory
diseases and risk factors, 1990-2019: an update from the Global
Burden of Disease Study 2019. Lancet. 2023:59;101936.
3. Singh D, et al.
ECLIPSE Investigators. Eosinophilic inflammation in COPD:
prevalence and clinical characteristics. Eur Respir
J. 2014;44:1697-1700.
4. Saha
S, et
al. Eosinophilic
airway inflammation in COPD. Int
J Chron Obstruct Pulmon Dis.
2006;1(1):39-47.
5. Maspero
J, et al. Type 2 inflammation in asthma and other airway
diseases. ERJ Open
Res.
2022;8:00576-2021.
6. GOLD
Science Committee Members (2023-2024). The Global Strategy for
Diagnosis, Management and Prevention of CO 2024. Available
at: www.goldcopd.org Last
accessed: July 2024
7. Hurst
JR, et al. Susceptibility
to Exacerbation in Chronic Obstructive Pulmonary
Disease. N Engl J
Med.
2010;363:1128-1138.
8. U.S.
Food and Drug Administration. Nucala Full Prescribing Information.
Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf.
Last accessed December 2023.
9. European
summary of product characteristics available at https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf
last accessed February 2023
10. Whittaker
H, et al. Frequency and Severity of Exacerbations of COPD
Associated with Future Risk of Exacerbations and Mortality: A UK
Routine Health Care Data Study. Int
J Chron Obstruct Pulmon Dis.
2022;17:427-437.
11. Rabe
KF, et al. Targeting Type 2 Inflammation and Epithelial Alarmins in
Chronic Obstructive Pulmonary Disease: A Biologics
Outlook. Am J Respir
Crit Care Med.
2023;208:396-405.
12. Buchheit
KM, et al. Mepolizumab targets multiple immune cells in
aspirin-exacerbated respiratory disease. J
Allergy Clin Immunol.
2021;148(2):574-584.
13. Barretto
KT, et al. Human airway epithelial cells express a functional IL-5
receptor. Allergy.
2020;75(8):2127-2130.
14. Bajbouj
K, et al. IL-5 receptor expression in lung fibroblasts: Potential
role in airway remodelling in asthma. Allergy.
2023;78(3):882-885.
15. Siddiqui
S, et al. Eosinophils and tissue remodeling: Relevance to airway
disease. J
Allergy Clin Immunol.
2023;152(4):841-857.
16. Bergantini
L, et al. Regulatory T cell monitoring in severe eosinophilic
asthma patients treated with mepolizumab. Scand
J Immunol.
2021;94(1):e13031.
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: September
06, 2024
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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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