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 May 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: 21
May 2024, London
UK
GSK announces positive results from phase III severe asthma trials
of depemokimab
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Primary
endpoints met in SWIFT-1 and SWIFT-2 trials with statistically
significant and clinically meaningful reductions in exacerbations
over 52 weeks vs. placebo
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Depemokimab
has the potential to be the first approved ultra-long-acting
biologic with
a six-month dosing schedule for severe asthma
●
Six-month
dosing could simplify treatment to support millions of patients
with severe asthma
GSK plc (LSE/NYSE: GSK) today announced positive headline results
from the phase III clinical trials SWIFT-1 and SWIFT-2, which
assessed the efficacy and safety of depemokimab versus placebo in
adults and adolescents with severe asthma with
type 2 inflammation characterised by blood eosinophil
count.1,2 Both
SWIFT-1 and SWIFT-2 met their primary endpoints of a reduction in
the annualised rate of clinically significant exacerbations (asthma
attacks) over 52 weeks.1,2 Across
both trials the overall incidence and severity of
treatment-emergent adverse events were similar in patients treated with
either depemokimab or placebo.
Further analysis of these data is ongoing.
Depemokimab is the first ultra-long-acting biologic to be evaluated
in phase III trials with a binding affinity and high potency
for interleukin-5 (IL-5), enabling six-month dosing intervals
for patients with severe asthma.1,2,3 IL-5
is known to be a key cytokine (protein) in type 2
inflammation.4,5 This inflammation,
typically identified by elevated
blood eosinophil count, is the underlying pathology responsible for
more than 80% of people with severe asthma and can lead to
unpredictable exacerbations.5,6
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology
R&D, said:
"These results add to the established body
of evidence that targeted inhibition of IL-5 plays a key
role in
reducing type 2 inflammation that drives severe asthma
exacerbations. Depemokimab
could offer the possibility of sustained
inhibition of
this pathway, with
a dosing schedule of just two injections per
year. This
is important as research
shows that 73% of physicians7 believe
longer dosing intervals would be beneficial to patients
who are often juggling multiple therapies."
Expertise in respiratory diseases and the science of IL-5 has
informed the ongoing evidence generation program evaluating the
impact of six-month dosing of sustained IL-5 inhibition in patients
achieving clinical remission in severe
asthma.5 The
full results of SWIFT-1 and SWIFT-2 will be presented at an
upcoming scientific congress and will be used to support regulatory submissions to
health authorities worldwide.
Depemokimab is currently not approved anywhere in the
world.
About the depemokimab development programme
The phase III programme consists of SWIFT-1
and SWIFT-2 in severe
asthma,
along with
an open label extension study (AGILE).1,2,8 SWIFT-1
and SWIFT-2 were replicate 52-week, randomised, double-blind,
placebo-controlled, parallel-group, multi-centre phase III clinical
trials.1,2 The
trials assessed the efficacy and safety of depemokimab adjunctive
therapy in 375 and 380 participants who were randomised to receive
depemokimab or a placebo, in addition to their standard of care
treatment with medium to high-dose inhaled corticosteroids plus at
least one additional controller.1,2
An additional study (NIMBLE) is underway to assess the efficacy and
safety of depemokimab when participants with severe asthma are
switched from mepolizumab or
benralizumab.9
Depemokimab's extended half-life has the potential to provide
sustained inhibition of broad inflammatory functions and is being
investigated in a variety of type 2 inflammatory
conditions.1,2,8-13 Depemokimab
is also currently being evaluated in phase III trials across a
range of other IL-5 mediated diseases, including eosinophilic
granulomatosis with polyangiitis (EGPA), chronic rhinosinusitis
with nasal polyps (CRSwNP) and hypereosinophilic syndrome
(HES).9-12
About severe asthma and type 2 inflammation
Severe
asthma is defined as asthma that requires treatment with high-dose
inhaled corticosteroids plus a second controller (and/or systemic
corticosteroids) or biologic therapy, to prevent it from becoming
'uncontrolled' or which remains 'uncontrolled' despite
therapy.5,14 In
more than 80% of patients with severe asthma, their condition is
driven by type 2 inflammation in which
patients exhibit elevated levels
of eosinophils (a type of white blood cell).5,6 Blood
eosinophils count can be measured via a simple blood
test. IL-5 is a core
cytokine (protein) in type 2 inflammation alongside IL-4 and
IL-13.5 Type
2 inflammation drives the underlying pathology in a variety of
immune-mediated conditions. IL-5 is responsible for the growth,
activity and survival of eosinophils.5
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.
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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Sarah Clements
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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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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 Q1 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References:
1.
ClinicalTrials.gov. Placebo-controlled Efficacy and Safety Study of
GSK3511294 (Depemokimab) in Participants With Severe Asthma With an
Eosinophilic Phenotype - (SWIFT-1) Available
at: https://classic.clinicaltrials.gov/ct2/show/NCT04719832 Last
accessed May 2024.
2. ClinicalTrials.gov.
A Study of GSK3511294 (Depemokimab) in Participants With Severe
Asthma With an Eosinophilic Phenotype (SWIFT-2) Available
at: https://classic.clinicaltrials.gov/ct2/show/NCT04718103 Accessed
May 2024.
3. Singh
D, et al. A Phase 1 study of the long-acting anti-IL-5 monoclonal
antibody GSK3511294 in patients with
asthma. Br J Clin
Pharmacol.
2022;88:702-712.
4. Principe
S, et
al. Severe
asthma: Targeting the IL-5 pathway. Clin Exp Allergy. 2021
Aug;51(8):992-1005
5. Global
Initiative for Asthma. Global Strategy for Asthma Management and
Prevention,2024. Updated May 2024. Available at: https://ginasthma.org/. Accessed
May 2024.
6. Heaney L, et
al. Eosinophilic
and Noneosinophilic Asthma: An Expert Consensus Framework to
Characterize Phenotypes in a Global Real-Life Severe Asthma
Cohort. Chest.
2021;160(3):814-830.
7. Research
Partnership Quant uptake Market Research, 200 HCPs Top two box on a
seven-point scale where seven equaled "highly
beneficial".
8. 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.
9. 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.
10. 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.
11. 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
May 2024
12. 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
May 2024.
13. ClinicalTrials.gov. Depemokimab
in Participants With Hypereosinophilic Syndrome, Efficacy, and
Safety Trial (DESTINY) Available
at: https://clinicaltrials.gov/study/NCT05334368 Accessed
May 2024.
14. GINA
Difficult-to-treat and severe asthma in adolescent and adult
patients: diagnosis and management. Global Strategy for Asthma
Management and Prevention 2021. Available at: https://ginasthma.org/wp-content/uploads/2021/08/SA-Pocket-guide-v3.0-SCREEN-WMS.pdf.
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: May
21, 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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