a8530k
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 April 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:
17 April 2024, London UK
EAGLE-1 phase III data show potential for gepotidacin as a new oral
treatment option for uncomplicated urogenital gonorrhoea (GC) amid
growing resistance to existing treatments
●
Gepotidacin achieved a 92.6% microbiological
success rate and was non-inferior to the leading combination treatment
●
EAGLE-1 is the
third positive pivotal trial for gepotidacin, a potential
first-in-class oral antibiotic as part of GSK's industry-leading
infectious diseases portfolio
●
Results will be
presented at European Society of Clinical Microbiology and
Infectious Diseases (ESCMID) Global
GSK plc
(LSE/NYSE: GSK) today announced positive results from the pivotal
EAGLE-1 phase III trial for gepotidacin, a potential first-in-class
oral antibiotic with a novel mechanism of action for uncomplicated
urogenital gonorrhoea (GC) in adolescents and adults. These results
will be presented on 30 April 2024 at the European Society of
Clinical Microbiology and Infectious Diseases (ESCMID) Global in
Barcelona, Spain.
The results from EAGLE-1 are based on a primary endpoint of
microbiological response (success or failure of eliminating the
bacterial cause of gonorrhoea) at the Test-of-Cure (ToC) visit 3-7
days after treatment. The trial showed that gepotidacin (oral, two
doses of 3,000mg) was non-inferior with 92.6% success rates when
compared to 91.2% success rates for intramuscular (IM) ceftriaxone
(500mg) plus oral azithromycin (1,000mg)
combined therapy,
a leading combination treatment regimen for
gonorrhoea.
The
safety and tolerability profile of gepotidacin in the EAGLE-1 trial
was consistent with results seen in phase I and II trials. The most
commonly reported adverse events (AEs) in gepotidacin subjects were
gastrointestinal (GI). All AEs were mild or moderate (Grade 1
or 2) except for one severe (Grade 3), unrelated event in each
treatment arm and one unrelated serious event in the gepotidacin
arm.
There
are an estimated 82 million new cases of gonorrhoea globally each
year.[1] In the United
States, rates of reported gonorrhoea have increased 118% from 2009
to 2021,[2] with 648,056
cases being reported to the US Centers for Disease Control and
Prevention (CDC) in 2022.[3] The CDC also
reported that approximately half of gonorrhoea cases each year in
the US are resistant to one antibiotic.[4]
Chris Corsico, SVP Development, GSK, said: "These results highlight the potential of
gepotidacin as a new oral treatment option given the rising
incidence of gonorrhoea worldwide including drug resistant
infections. The imperative for innovative treatments has never been
clearer. We are committed to working with health regulators
globally to introduce this potential new antibiotic, focusing on
solutions that meet critical patient needs."
Gonorrhoea
is a sexually transmitted infection caused by bacteria
called Neisseria
gonorrhoeae, which has been recognised by the World
Health Organisation as a priority pathogen. It affects both men and
women and if inadequately treated, it can lead to infertility and
other sexual and reproductive health complications. It also
increases the risk of HIV infection.
GSK is also developing gepotidacin for the potential treatment of
uncomplicated urinary tract infections (uUTI). Positive phase III
data from the EAGLE-2 and EAGLE-3 trials were presented at the
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID) in April 2023, and published in The
Lancet.[5] If approved, gepotidacin could be the first
in a new class of oral antibiotics in uUTI in over 20
years. EAGLE-1 is the third positive pivotal trial for
gepotidacin.
The
development of gepotidacin has been funded in whole or 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
has now been completed. The programme comprises of three
trials:
EAGLE-1
(non-inferiority urogenital gonorrhoea trial) compared the efficacy
and safety of gepotidacin to ceftriaxone plus azithromycin in
approximately 600 patients with uncomplicated urogenital
gonorrhoea.
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). Across both trials, the duration for participants
was approximately 28 days, and the primary endpoint was the
combined clinical and microbiological response at the ToC visit
(days 10-13) in patients with qualifying uropathogens susceptible
to nitrofurantoin.
About Gepotidacin
Gepotidacin,
discovered by GSK scientists, is an investigational bactericidal,
first-in-class triazaacenaphthylene antibiotic that inhibits
bacterial DNA replication by a novel mechanism of action and
binding site and for most pathogens provides well-balanced
inhibition of two different Type II topoisomerase enzymes. This
provides activity against most strains of target uropathogens,
(such as E.
coli and S.
saprophyticus), and N.
gonorrhoeae, including isolates resistant to several
antibiotics. Due to the well-balanced inhibition of two enzymes,
gepotidacin target-specific mutations in both enzymes are needed to
significantly affect gepotidacin susceptibility.
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. GSK's 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 (cUTI), to the pipeline. 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.
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)
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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 the company's Annual Report on Form 20-F for
2023.
Registered
in England & Wales:
No.
3888792
Registered
Office:
980 Great West
Road
Brentford,
Middlesex
TW8
9GS
[1] World Health Organisation, Multi-drug resistant
gonorrhoea. Available at: https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea
[2] CDC data on file
[3] CDC, Sexually Transmitted Infections
Surveillance. Available at: https://www.cdc.gov/std/statistics/2022/default.htm#:~:text=In%202022%2C%20more%20than%202.5,from%20all%20STI%20prevention%20partners
[4] Centers for Disease Control and Prevention.
Combating the Threat. Available at: https://www.cdc.gov/std/gonorrhea/drug-resistant/carb.htm#:~:text=There%20are%20more%20than%20500%2C000%20reported%20cases%20of,year%20are%20resistant%20to%20at%20least%20one%20antibiotic.
[5] The Lancet, Oral gepotidacin versus
nitrofurantoin in patients with uncomplicated urinary tract
infection (EAGLE-2 and EAGLE-3): two randomised, controlled,
double-blind, double-dummy, phase 3, non-inferiority trials,
available at:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02196-7/abstract
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: April
17, 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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