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 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(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: 14 October
2024, London
UK
GSK announces positive phase III
results from ANCHOR trials for depemokimab
in chronic rhinosinusitis
with nasal polyps
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Primary endpoints met with statistically
significant reduction in nasal polyp size and nasal obstruction
versus placebo plus
standard of care, at
52 weeks
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Depemokimab is an
ultra-long-acting biologic administered
once every six months
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Patients
with chronic rhinosinusitis with nasal polyps (CRSwNP) experience a
range of symptoms which are widely underestimated and often
sub-optimally treated
GSK plc (LSE/NYSE: GSK) today announced positive headline results
from the phase III clinical trials ANCHOR-1 and ANCHOR-2, which
assessed the efficacy and safety of depemokimab versus placebo in
adults with CRSwNP. Both trials met their co-primary endpoints of a
change from baseline in total endoscopic nasal polyp score at 52
weeks and change from baseline in mean nasal obstruction score from
weeks 49 to 52. The overall incidence and severity of
treatment-emergent adverse events across both trials were similar
in patients treated with either depemokimab or placebo. Further
analysis of these data is ongoing. The full results of ANCHOR-1 and
ANCHOR-2 will be presented at an upcoming scientific
congress.
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D
at GSK, said: "Globally
millions of people suffer from uncontrolled CRSwNP, the majority of
whom will exhibit markers of type 2 inflammation. These patients
have high corticosteroid exposure and often experience recurrence
of nasal polyps following surgery. We're very encouraged by the
results from the ANCHOR studies, which demonstrate the potential
for depemokimab to offer targeted and sustained suppression of a
key inflammatory pathway underlying nasal polyp growth and nasal
obstruction. Today's data, along with recent phase III data in
severe asthma, will be used in regulatory filings around the
world."
Depemokimab is the first ultra-long-acting biologic to be evaluated
in phase III trials with an extended half-life and high binding
affinity and potency for interleukin-5 (IL-5), which could enable
dosing once every six-months for patients with
CRSwNP.1-3 IL-5 is
present at high levels in nasal polyp tissue and is
a key cytokine (protein) in type 2 inflammation.1,4-7
These data are part of GSK's aspirations to advance treatment goals
for those with type 2 inflammatory conditions like
CRSwNP. Being
able to deliver sustained suppression of
inflammation that
drives the disease and its progression, has
the potential to benefit patients and clinicians by reducing the
risk of inflammation reoccurring due to missed doses. Increased
dosing intervals may also reduce
the need for regular clinic time.
CRSwNP is a
chronic condition that affects up to
4% of the general population, of whom 40% have uncontrolled
disease.8,9 It
is caused by inflammation of the nasal lining that can lead to soft
tissue growths, known as nasal polyps.4,10 People
with CRSwNP experience
symptoms such as nasal obstruction, loss
of smell, facial pressure, sleep disturbance, infections and nasal
discharge that can
significantly affect their emotional and physical
well-being.4,10
Up to 80% of people with CRSwNP show evidence of type 2 airway
inflammation, typically detected by blood eosinophil count as a
biomarker, which is associated with more severe disease and
symptoms.4-7,11These
patients are
likely to have a history of sinonasal surgery, which is accompanied
by a high risk of nasal polyp recurrence
and have high OCS
use that is known to be
associated with severe complications.7,10,11
Data from ANCHOR-1 and ANCHOR-2 along with data from SWIFT-1 and
SWIFT-2, the phase III trials of depemokimab in severe asthma, will
be used in regulatory filings around the
world. Depemokimab
is currently not approved anywhere.
About ANCHOR-1 and ANCHOR-21,2
ANCHOR-1 and ANCHOR-2 were replicate phase III clinical trials
assessing the safety and efficacy of depemokimab in patients with
CRSwNP. Both were 52-week, randomised, double-blind, parallel
group, placebo controlled, multi-centre trials. Number
of subjects included in the Full Analysis Set of ANCHOR-1:
depemokimab = 143, placebo = 128 and in ANCHOR-2: depemokimab =
129, placebo = 128.
About the depemokimab development programme
Depemokimab's
extended half-life, high potency and high binding affinity for IL-5
means it has the potential
to provide sustained inhibition of broad inflammatory functions
with dosing once every six-months. The phase III
programme includes evaluation of depemokimab in other IL-5 mediated diseases. These include
severe asthma,3,13,14 eosinophilic granulomatosis with
polyangiitis (EGPA)14 and hypereosinophilic syndrome
(HES).15 The first phase III trials in severe
asthma, SWIFT-1 and SWIFT-2, have been reported and published in
the New England Journal of
Medicine.3
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.
GSK enquiries
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Media:
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Tim Foley
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Dan Smith / 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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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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Annabel Brownrigg-Gleeson
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+44 (0) 7901 101944
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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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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:
79
New Oxford Street
London
WC1A
1DG
References
1. ClinicalTrials.gov. Efficacy
and Safety of Depemokimab (GSK3511294) in Participants With Chronic
Rhinosinusitis With Nasal Polyps (ANCHOR-1). Available
at: https://clinicaltrials.gov/study/NCT05274750 Accessed
Oct 2024
2. ClinicalTrials.gov. Efficacy
and Safety of Depemokimab (GSK3511294) in Participants With Chronic
Rhinosinusitis With Nasal Polyps (ANCHOR-2). Available
at: https://clinicaltrials.gov/study/NCT05281523
Accessed Oct 2024
3. Jackson DJ,
et al. Six Monthly Depemokimab in Severe Asthma With an
Eosinophilic Phenotype. NEJM.
Published on September 9 at https://www.nejm.org/doi/full/10.1056/NEJMoa2406673
4. Bachert
C, et al. Burden of Disease in Chronic Rhinosinusitis with Nasal
Polyps. J
Asthma Allergy.
2021;b 11;14:127-134. doi: 10.2147/JAA.S290424. PMID: 33603409;
PMCID: PMC7886239.
5. Han JK, et
al. Mepolizumab for chronic rhinosinusitis with nasal polyps
(SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3
trial. Lancet Respir
Med. 2021;9(10):1141-1153.
6. Kato A, et al. Endotypes of
chronic rhinosinusitis: Relationships to disease phenotypes,
pathogenesis, clinical findings, and treatment
approaches. Allergy. 2022;77(3):812-826.
7. De
Corso E, et al. How to manage recurrences after surgery in CRSwNP
patients in the biologic era: a narrative
review. Acta
Otorhinolaryngol Ital. 2023;43(Suppl.
1):S3-S13.
8. Chen
S, et al. Systematic literature review of the epidemiology and
clinical burden of chronic rhinosinusitis with nasal
polyposis. Curr
Med Res Opin.
2020;36(11):1897-1911.
9. van der Veen J, et al.
Real-life study showing uncontrolled rhinosinusitis after sinus
surgery in a tertiary referral centre. Allergy.
2017;72(2):282-290.
10. Bachert C, et al.
EUFOREA expert board meeting on uncontrolled severe chronic
rhinosinusitis with nasal polyps (CRSwNP) and biologics:
Definitions and management. J
Allergy Clin Immunol.
2021;147(1):29-36.
11. Laidlaw TM, et al. Chronic
Rhinosinusitis with Nasal Polyps and
Asthma. J. Allergy Clin.
Immunol.
2001;9(3):1133-1141.
12. Silver
J, et al. Biologic use and treatment patterns in patients
with chronic rhinosinusitis with nasal polyps: a US real-world
study. Allergy
Asthma Clin Immunol. 2023;19(1):104.
13. ClinicalTrials.gov. An
Open-Label Extension Study of GSK3511294 (Depemokimab) in
Participants Who Were Previously Enrolled in 206713 (NCT04719832)
or 213744 (NCT04718103) (AGILE). Available at: https://clinicaltrials.gov/study/NCT05243680 Last
accessed May 2024.
14. ClinicalTrials.gov. A
Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or
Benralizumab in Participants With Severe Asthma With an
Eosinophilic Phenotype (NIMBLE). Available at: https://clinicaltrials.gov/study/NCT04718389 Accessed
May 2024.
15. ClinicalTrials.gov. Efficacy
and Safety of Depemokimab Compared With Mepolizumab in Adults With
Relapsing or Refractory Eosinophilic Granulomatosis With
Polyangiitis (EGPA). Available at: https://clinicaltrials.gov/study/NCT05263934 Accessed
May 2024.
16. ClinicalTrials.gov. Depemokimab
in Participants With Hypereosinophilic Syndrome, Efficacy, and
Safety Trial (DESTINY). Available
at: https://clinicaltrials.gov/study/NCT05334368
Accessed May 2024.
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
14, 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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