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 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: 21 October 2025, London UK
Positive PIVOT-PO phase III data show tebipenem HBr's potential as
the first oral carbapenem antibiotic for patients with complicated
urinary tract infections (cUTIs)
● Data
presented at IDWeek 2025 after study stopped early for
efficacy
● Primary endpoint met, demonstrating
non-inferiority of oral tebipenem HBr compared to intravenous
treatment1
●
A new oral option may
reduce the need for cUTI treatment in hospital
setting
● Data
will be shared with regulatory authorities to support regulatory
filings
GSK plc (LSE/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today
announced full results of the positive pivotal phase III PIVOT-PO
trial evaluating tebipenem HBr, an investigational oral treatment
for complicated urinary tract infections (cUTIs), including
pyelonephritis (NCT06059846). These
results were presented on 20 October 2025 in a late-breaking oral
abstract session at ID Week 2025 in Atlanta,
USA.
Complicated UTIs represent an important health issue, with an
estimated 2.9 million cases of cUTIs treated annually in the US
alone.2 These
infections are often caused by multidrug-resistant
pathogens3 and
carry serious risks including organ failure, sepsis,
and even death.3-5 They
also result in significant emergency department visits and
hospitalisations, contributing to over
$6 billion per year in healthcare costs.6 Current
standard of care includes carbapenem antibiotics in cases of sepsis
or resistance to other antibiotics but they are only available for
intravenous administration typically occurring in hospital
setting.7,8
The trial, which was stopped early for efficacy in May,
demonstrated non-inferiority of tebipenem
HBr compared
to intravenous imipenem-cilastatin
in hospitalised patients with cUTI, including pyelonephritis,
based on the overall response (composite of clinical cure plus
microbiological eradication of the bacteria causing the infection)
at the test of cure visit. Tebipenem
HBr (oral, 600 mg) achieved a 58.5%
overall success rate (261/446 participants) compared
to 60.2% overall success rate (291/483
participants) for
imipenem-cilastatin (intravenous, 500 mg) (adjusted
treatment difference: −1.3%; 95% CI: −7.5%, 4.8%). The
safety profile of tebipenem HBr was generally similar to that of
imipenem-cilastatin and other carbapenem antibiotics. The most
frequently reported adverse events (in ≥3% of patients who
received tebipenem HBr) were diarrhea and headache; these events
were all mild or moderate and non-serious.
Tony Wood, Chief Scientific Officer, GSK, said:
"Complicated
UTIs can have serious consequences for patients, including organ
failure and sepsis, and oral options for drug-resistant infections
are limited. These ground-breaking data show for the first time
that cUTIs, including pyelonephritis, can be treated with an oral
carbapenem antibiotic as effectively as with an intravenous one. We
have a long-standing commitment to delivering novel anti-infectives
and are delighted to offer the potential of tebipenem HBr as an
effective oral alternative that could be taken at
home".
Esther Rajavelu, Chief Executive Officer, Spero
Therapeutics, said: "These data
presented at IDWeek represent the culmination of years of dedicated
work by our team in close collaboration with GSK. We are deeply
grateful to the physicians, researchers, support staff, and, most
importantly, to the patients who made this study, and the ones
before it, possible. Along with GSK, we are now focused on
advancing tebipenem HBr toward FDA submission and bringing this
important therapy to patients in need."
Dr George Sakoulas, Adjunct Professor Department of Pediatrics,
UCSD School of Medicine and Chief Infectious Diseases Sharp Rees
Stealy Medical Group, commented: "Increasing antibiotic resistance among
community-acquired bacteria that cause cUTIs is greatly amplifying
the burden of treatment for patients, clinicians, and payers. The
therapeutic flexibility of a new oral antibiotic may reduce the
need for intravenous antibiotics to treat cUTI, providing benefit
to patients and improving treatment options."
Secondary endpoints also show:
● Clinical
cure (i.e. absence of symptoms) rates at test of cure visit were
93.5% in the tebipenem HBr group (417/446) compared to 95.2% in
the imipenem-cilastatin group
(460/483) with adjusted treatment difference: −1.6% (95% CI:
−4.7%, 1.4%)
●
Microbiological
response rates at test of cure visit were 60.3% in the tebipenem
HBr group (269/446) compared to 61.3% in the imipenem-cilastatin
group (296/483)
with adjusted treatment difference: −0.8% (95% CI:
−6.9%, 5.3%)
● Overall,
clinical and microbiological response rates at test of cure in
participants with infections caused by antimicrobial-resistant
Enterobacterales were consistent with the respective response rates
in the primary analysis population.
GSK plans to work with US regulatory authorities to include the
data as part of a filing in Q4 2025. If
approved, tebipenem HBr would be the first oral carbapenem
antibiotic in the US for
patients who suffer from cUTIs, adding to GSK's
growing anti-infectives portfolio and helping address the
challenges of antimicrobial resistance (AMR).
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.
About tebipenem HBr
Tebipenem pivoxil as hydrobromide salt (Tebipenem 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 was a global, randomised, double-blind, pivotal,
non-inferiority (NI margin: -10%) Phase 3 clinical trial of oral
tebipenem HBr compared to IV imipenem-cilastatin, 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-cilastatin
(500 mg) IV every six hours, for a total of seven to ten days.
Matching placebos were used to maintain blinding. The primary
efficacy endpoint was overall response (composite of clinical cure
plus microbiological eradication) at the test-of-cure visit (about
17 days from first dose administration of study drug) in patients
with qualifying pathogens susceptible to imipenem. The trial
enrolled a total of 1,690 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.3 Definitions
of cUTIs are not currently uniform among international societies
and regulatory agencies.5,
9 cUTIs
encompass a heterogeneous patient population due to the wide range
of host factors, comorbidities and urological abnormalities
associated with cUTIs.5,
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.3,
10-13
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 and treat disease, and potentially 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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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 Q2 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1. Hong D. et al, Oral Tebipenem
Pivoxil Hydrobromide vs Intravenous Imipenem-Cilastatin in Patients
with Complicated Urinary Tract Infections or Acute Pyelonephritis:
Efficacy and Safety Results from the Phase 3 PIVOT-PO study, Oral
presentation at ID Week 2025, 20 October 2025.
.
2. 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.
3. Sabih A, Leslie SW. Complicated
urinary tract infections. In: StatPearls. 2023. StatPearls
Publishing: Treasure Island, FL, USA.
4. 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.
5. Marantidis J, Sussman RD. Unmet
Needs in Complicated Urinary Tract Infections: Challenges,
Recommendations, and Emerging Treatment
Pathways. Infect Drug
Resist.
2023:16:1391-1405.
6. 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.
7. Cotroneo, N., et al. In Vitro and
In Vivo Characterization of Tebipenem, an Oral
Carbapenem. Antimicrobial
agents and chemotherapy. 2020. 64(8),
e02240-19.
8. Maeda M, et al. Efficacy of
carbapenems versus alternative antimicrobials for treating
complicated urinary tract infections caused by
antimicrobial-resistant Gram-negative bacteria: protocol for a
systematic review and meta-analysis. BMJ
Open. 2023 Apr
21;13(4):e069166.
9. Fernandez MM, et al. Poster
presented at ESCMID Global, 27-30 April 2024, Barcelona, Spain.
Poster P1023.
10. Bonkat G, et al. Keep it Simple:
A Proposal for a New Definition of Uncomplicated and Complicated
Urinary Tract Infections from the EAU Urological Infections
Guidelines Panel. Eur
Urol. 2024;86(3):195-197.
11. Wagenlehner FME, et al.
Epidemiology, definition and treatment of complicated urinary tract
infections. Nat Rev
Urol.
2020;17(10):586-600.
12. 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.
13. Altunal N, et al. Ureteral stent
infections: a prospective study. Braz J Infect
Dis.
2017;21(3):361-364.
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
21, 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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