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 2025
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: 28 May 2025, London UK
PIVOT-PO phase III study for tebipenem HBr stopped early for
efficacy following review by Independent Data Monitoring
Committee
●
If
approved, tebipenem HBr could be the first oral carbapenem
antibiotic for US patients with complicated urinary tract
infections (cUTIs)
●
Data
to be part of a planned US FDA filing in H2
2025
●
An
estimated 2.9 million cases of cUTIs
are treated annually in the US[1] with
many cases requiring hospitalisation, contributing
to over
$6 billion per year in healthcare costs[2]
●
GSK's
second anti-infective programme stopped early for efficacy in Phase
III after EAGLE 2 and 3 for gepotidacin[3]
GSK plc (LSE/NYSE: GSK) and Spero Therapeutics today announced that
the pivotal phase III PIVOT-PO trial evaluating tebipenem HBr, an
investigational oral treatment for complicated urinary tract
infections (cUTIs), including pyelonephritis, will stop early for
efficacy (NCT06059846). The
decision follows a recommendation from an Independent Data
Monitoring Committee (IDMC), based on a planned interim analysis of
data from 1,690 patients enrolled in the study. If
approved, tebipenem HBr would be the first oral carbapenem
antibiotic for
patients in the US who suffer from cUTIs, adding
to GSK's
innovative anti-infectives portfolio and helping address the
challenges of antimicrobial resistance (AMR).
The trial met the primary endpoint of
non-inferiority of
tebipenem HBr compared to intravenous imipenem-cilastatin in
hospitalised adult patients with cUTI, including
pyelonephritis, on
overall response (composite of clinical cure plus microbiological
eradication) at the test-of-cure visit. The
IDMC review did not identify any new safety concerns beyond what
has been reported in other studies with
tebipenem, with
diarrhea and headache as the two most reported adverse
events. GSK
plans to work with US regulatory authorities to include the data as
part of a filing in H2 2025. Full
results will be submitted for presentation at an upcoming
scientific congress and for publication in a peer-reviewed
journal.
Tony Wood, Chief Scientific Officer, GSK, said: "Complicated
UTIs can have a profound impact on patients and carry a high risk
of clinical complications, including sepsis and septic
shock.[4],[5],[6] Currently
many need hospital-based intravenous treatment due to limited oral
options for drug-resistant infections, contributing to over $6
billion per year in US healthcare costs2.
These positive results add to our growing anti-infectives portfolio
and reinforce the potential of tebipenem HBr as an effective oral
alternative taken at home".
An estimated 2.9 million cases of cUTIs are treated annually in the
US alone.1 These
infections are often caused by multidrug-resistant
pathogens1 and
carry increased risk of morbidity and mortality.4,7 Current
standard of care includes carbapenem antibiotics, especially in
case of sepsis and allergies or resistance to other antibiotics,
but they are only available for IV administration. This results in
significant emergency department visits and
hospitalisations.6,[7],[8]
Esther Rajavelu, Chief Executive Officer, Spero
Therapeutics, said: "We're
proud of today's positive result for patients diagnosed with cUTI,
including pyelonephritis, where oral treatments are much
needed. We look forward to working with GSK on next steps for
tebipenem HBr, and would like to thank the patients, investigators,
and other clinical staff who have participated in PIVOT-PO trial to
reach this advanced stage."
The development of tebipenem HBr is supported in part with federal
funds from the U.S. Department of Health and Human Services;
Administration for Strategic Preparedness and Response; Biomedical
Advanced Research and Development Authority (BARDA), under contract
number HHSO100201800015C. It is GSK's second anti-infective
programme to be stopped early for efficacy in Phase III, following
the EAGLE 2 and EAGLE 3 trials for gepotidacin in
2022.3
About tebipenem HBr
Tebipenem pivoxil hydrobromide
(HBr) is a late-stage development asset developed in collaboration
with Spero Therapeutics. Tebipenem HBr is being developed to treat
cUTIs, including pyelonephritis. In September 2022, GSK entered
into an exclusive license agreement with Spero Therapeutics for the
development and commercialisation of tebipenem HBr in all markets,
except certain Asian territories. Under
this agreement GSK has sub-licensed back to Spero Therapeutics the
rights and responsibility to conduct certain development work
including the PIVOT-PO Phase III study, after which sponsorship of
the new drug application (NDA) will be transferred to GSK from
Spero Therapeutics. Tebipenem HBr has received Qualified Infectious
Disease Product (QIDP) and Fast Track designations from the US
FDA.
About the PIVOT-PO trial
PIVOT-PO is a global, randomised,
double-blind, pivotal Phase III clinical trial of oral tebipenem
pivoxil HBr compared to IV imipenem, in hospitalised adult patients
with cUTI including
pyelonephritis. Patients were randomised 1:1 to receive tebipenem
pivoxil (600 mg) orally every six hours, or imipenem-cilastin (500
mg) IV every six hours, for a total of seven to ten days. Matching
placebos are used to maintain blinding. The primary efficacy
endpoint is overall response (composite of clinical cure plus
microbiological eradication) at the test-of-cure visit. The primary
analysis for the trial is an assessment of non-inferiority in the
primary analysis population. The
trial enrolled a total of 1690 patients, with randomisation
stratified by age, baseline diagnosis (cUTI or pyelonephritis),
and the presence or absence of urinary tract instrumentation. For
further details on the trial, refer to clinicaltrials.gov
identifier NCT06059846.
About complicated urinary tract infections
(cUTIs)
cUTIs are broadly described as
any UTI that carries an increased risk of morbidity and
mortality.4 Definitions
of cUTIs are not currently uniform among international societies
and regulatory agencies.[9] cUTIs
encompass a heterogeneous patient population due to the wide range
of host factors, comorbidities and urological abnormalities
associated with cUTIs.4,9 Risk
factors for cUTI include indwelling catheters, ureteric stents,
neurogenic bladder, obstructive uropathy, urinary retention,
urinary diversion, kidney stones, diabetes mellitus, immune
deficiency, urinary tract modification, and UTIs in renal
transplant patients.[10]
GSK in infectious diseases
GSK has pioneered innovation in infectious diseases for over 70
years, and the Company's pipeline of medicines and vaccines is one
of the largest and most diverse in the industry, with a goal of
developing preventive and therapeutic treatments for multiple
disease areas or diseases with high unmet needs globally. Our
expertise and capabilities in infectious disease strongly position
us to help prevent disease and mitigate the challenge of
antimicrobial resistance (AMR).
About Spero Therapeutics
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a
clinical-stage biopharmaceutical company focused on identifying and
developing novel treatments for rare diseases and multi-drug
resistant (MDR) bacterial infections with high unmet need. For more
information, visit www.sperotherapeutics.com
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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Relations:
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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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q1 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
[1] Carreno
JJ, et al. Longitudinal, Nationwide, Cohort Study to Assess
Incidence, Outcomes, and Costs Associated With Complicated Urinary
Tract Infection. Open Forum
Infect Dis.
2019;6:ofz446.
[2] Lodise
TP, et al. Hospital admission patterns of adult patients with
complicated urinary tract infections who present to the hospital by
disease acuity and comorbid conditions: How many admissions are
potentially avoidable? Am J Infect
Control.
2021;49(12):1528-1534.
[3] GSK
press release, 3 November 2022 - available at: https://www.gsk.com/en-gb/media/press-releases/gsk-announces-phase-iii-trials-for-gepotidacin/
[4] Sabih
A, Leslie SW. Complicated urinary tract
infections. StatPearls.
2023. StatPearls Publishing: Treasure Island, FL,
USA.
[5] Zilberberg
MD, et al. Descriptive
Epidemiology and Outcomes of Hospitalisations With Complicated
Urinary Tract Infections in the United States,
2018. Open
Forum Infect Dis.
2022;9:ofab591.
[6] Li
HK, et al. An Unsupported Preference for Intravenous
Antibiotics. PLoS
Med.
2015;12:e1001825.
[7] Vallejo-Torres
L, et al. Cost
of hospitalised patients due to complicated urinary tract
infections: a retrospective observational study in countries with
high prevalence of multidrug-resistant Gram-negative bacteria: the
COMBACTE-MAGNET, RESCUING study. BMJ
Open.
2018;8:e020251.
[8] Lodise
TP, et al. Retrospective Cohort Study of the 12-Month Epidemiology,
Treatment Patterns, Outcomes, and Health Care Costs Among Adult
Patients With Complicated Urinary Tract
Infections. Open Forum
Infect Dis. 2022;9:ofac307.
[9] Marantidis
J, Sussman RD. Unmet Needs in Complicated Urinary Tract Infections:
Challenges, Recommendations, and Emerging Treatment
Pathways. Infect Drug
Resist.
2023:16:1391-1405.
[10] Gomila
A, et al. Predictive factors for multidrug-resistant gram-negative
bacteria among hospitalised patients with complicated urinary tract
infections. Antimicrob
Resist Infect Control. 2018;7:111.
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
28, 2025
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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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