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:
16 October 2024, London UK
Gepotidacin accepted for priority review by US FDA for treatment of
uncomplicated urinary tract infections in female adults and
adolescents
●
Application
supported by positive results from pivotal phase III EAGLE-2 and
EAGLE-3 trials
●
26 March
2025 assigned as action date for
FDA decision
●
Gepotidacin
could be the first in a new class of oral antibiotic treatment for
uUTIs in over 20 years
GSK plc
(LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has accepted the New Drug Application (NDA)
for gepotidacin, an investigational, first-in-class oral antibiotic
with a novel mechanism of action for the treatment of female adults
(³40 kg) and adolescents (³12 years, ³40 kg) with
uncomplicated urinary tract infections (uUTIs).
The FDA has granted Priority Review for this
application and assigned a Prescription Drug User Fee Act (PDUFA)
action date of 26 March 2025.
Over
half of all women are affected by uUTIs in their
lifetime[1],
with approximately 30% suffering from recurrent disease which can
cause significant patient burden, including discomfort and
restriction of daily activities.
[2] New
treatments are needed as the number of uUTIs caused by
drug-resistant bacteria is increasing and can result in higher
treatment failure rates.[3] Gepotidacin
is a late-stage antibiotic in GSKÕs growing infectious disease
portfolio and could be the first in a new class of oral antibiotics
for uUTIs in over 20 years.
The NDA is supported by positive results from the pivotal phase III
EAGLE-2 and EAGLE-3 trials. In these studies, gepotidacin demonstrated non-inferiority to
nitrofurantoin, the current standard of care for uUTI, in female
adults (³40 kg) and adolescents (³12 years, ³40 kg)
with a confirmed uUTI and a uropathogen susceptible to
nitrofurantoin. In EAGLE-3, gepotidacin achieved statistically
significant superiority versus nitrofurantoin, demonstrating
therapeutic success in 58.5% (162/277) of participants compared to
43.6% (115/264) for nitrofurantoin (treatment difference 14.6%, 95%
CI (6.4, 22.8)). In EAGLE-2, gepotidacin demonstrated therapeutic
success in 50.6% (162/320) of participants compared to 47.0%
(135/287) for nitrofurantoin (treatment difference 4.3%, 95% CI
(-3.6, 12.1)).
The safety and tolerability profile of gepotidacin in the EAGLE-2
and EAGLE-3 phase III trials was consistent with previous trials of
gepotidacin. The most commonly reported adverse events (AEs) in
gepotidacin participants were gastrointestinal (GI). Diarrhoea was
the most common (16% of participants), followed by nausea (9%). Of
the participants who reported GI AEs in the gepotidacin group, the
maximum severity were mild (69% Grade 1) and moderate (28% Grade
2). Participants with Grade 3 GI events accounted for
3% of all patients with GI events and occurred in <1% of all
participants. There was one drug-related serious adverse event in
each treatment arm (gepotidacin and nitrofurantoin) across the two
trials.
The
development of gepotidacin has been funded in part with federal
funds from the US Department of Health and Human Services,
Administration for Strategic Preparedness and Response, Biomedical
Advanced Research and Development Authority (BARDA), under Other
Transaction Agreement number HHSO100201300011C and with federal
funds awarded by the Defense Threat Reduction Agency under
agreement number HDTRA1-07-9-0002.
About the EAGLE (Efficacy of Antibacterial Gepotidacin Evaluated)
phase III programme
The
global phase III clinical programme for gepotidacin in adults and
adolescents consists of three trials:
EAGLE-2
and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and
safety of gepotidacin (1,500mg administered orally twice daily for
five days) to nitrofurantoin (100mg administered orally twice daily
for five days) with 1531 and 1605 female adults and adolescents
with uncomplicated urinary tract infections, respectively. Across
both trials, the duration of follow-up for participants was
approximately 28 days, and the primary endpoint was the combined
clinical and microbiological response at the Test-of-Cure (ToC)
visit (days 10-13) in patients with qualifying uropathogens
susceptible to nitrofurantoin.
EAGLE-1
(non-inferiority urogenital gonorrhoea trial) compared the efficacy
and safety of gepotidacin to ceftriaxone plus azithromycin in 628
patients with uncomplicated urogenital gonorrhoea caused
by Neisseria
gonorrhoeae.
About gepotidacin
Gepotidacin,
discovered by GSK scientists, is an investigational bactericidal,
first-in-class triazaacenaphthylene antibiotic that inhibits
bacterial DNA replication by a distinct binding site, a novel
mechanism of action and for most pathogens, provides well-balanced
inhibition of two different Type II topoisomerase enzymes. This
provides activity against most target uropathogens (such
as E.
coli and S.
saprophyticus), and N.
gonorrhoeae, including isolates resistant to current
antibiotics. Efficacy and safety in patients have been demonstrated
in uUTI and gonorrhoea phase III clinical trials, including those
with drug-resistant pathogens. Due to the well-balanced inhibition,
gepotidacin target-specific mutations in both enzymes are needed to
significantly affect susceptibility to gepotidacin. Therefore,
leading to a lower potential for resistance
development.
GSK in infectious diseases
GSK has
pioneered innovation in infectious diseases for over 70 years, and
the CompanyÕs 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. GSKÕs expertise and
capabilities in innovation, access and stewardship position the
Company uniquely to help prevent and mitigate the challenge of
antimicrobial resistance.
In
antimicrobials, in addition to gepotidacin, GSK entered into an
exclusive licence agreement with Spero Therapeutics, Inc. in
September 2022 to add tebipenem HBr, a late-stage antibiotic and
potential treatment for complicated urinary tract infections
(cUTIs), to the pipeline and are currently enrolling for PIVOT-PO,
a phase III trial. In March 2023, GSK announced an exclusive
licence agreement with Scynexis for Brexafemme (ibrexafungerp
tablets), a first-in-class antifungal for the treatment of
vulvovaginal candidiasis (VVC) and reduction in the incidence of
recurrent VVC.
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 under Item 3.D
ÒRisk factorsÓ in GSKÕs Annual Report on Form 20-F
for 2023, and GSKÕs Q2 Results for 2024.
Registered
in England & Wales:
No.
3888792
Registered Office:
79 New Oxford Street
London
WC1A 1DG
[1] Czajkowski, K., et al. Urinary tract infection in
women. Prz
Menopauzalny.
2021;20(1):40-7.
[2] Little P, Merriman R, Turner S, et al.
Presentation, pattern, and natural course of severe symptoms, and
role of antibiotics and antibiotic resistance among patients
presenting with suspected uncomplicated urinary tract infection in
primary care: observational study. BMJ.
2010;340:b5633.
[3] Kaye KS, et al. Antimicrobial resistance trends
in urine Escherichia coli isolates from adult and adolescent
females in the United States from 2011 to 2019: rising ESBL strains
and impact on patient management. Clin Infect Dis
2021;73:1992Ð1999. doi:
10.1093/cid/ciab560
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
16, 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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