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 February 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: 26 February 2024, London UK
GSK announces positive headline results from EAGLE-1 phase III
trial for gepotidacin in uncomplicated urogenital gonorrhoea
(GC)
●
EAGLE-1 trial met its
primary efficacy endpoint of non-inferiority comparing gepotidacin
with intramuscular ceftriaxone plus oral azithromycin combination
therapy
●
Neisseria
gonorrhoeae,
the bacteria causing gonorrhoea, is recognised by the World Health
Organisation as a priority pathogen, for which resistance to
existing treatments is rising
● Gepotidacin, a late-stage
antibiotic in GSK's industry-leading infectious diseases portfolio,
is also in development for uncomplicated urinary tract infections
(uUTI)
GSK plc (LSE/NYSE: GSK) today announced positive
headline 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
in adolescents and adults. The trial met its primary efficacy
endpoint, with gepotidacin (oral, two doses of 3,000mg)
demonstrating non-inferiority to
intramuscular (IM) ceftriaxone
(500mg) plus oral azithromycin
(1,000mg), a leading
combination treatment regimen for
gonorrhoea. The result is based on
a primary endpoint of microbiological response (success or failure)
at the Test-of-Cure (ToC) visit 3-7 days after
treatment.
Chris Corsico, Senior Vice President, Development, GSK,
said: "With
rising incidence rates and concern around growing resistance to
existing treatments, gonorrhoea poses a threat to public health
globally. These positive headline results demonstrate the potential
for gepotidacin to provide a novel oral treatment option in the
face of rising resistance and for patients who cannot take other
treatments due to allergies or intolerance."
Gonorrhoea is a sexually transmitted infection caused by bacteria
called Neisseria
gonorrhoeae. It
has been estimated that there are 82 million new cases globally
each year.[i] In
the United States, rates of reported gonorrhoea have increased 118%
from 2009 to 2021[ii],
with 648,056
cases being reported to the US Centers for Disease Control and
Prevention (CDC) in 2022.[iii] Gonorrhoea
affects both men and women and
if left untreated or inadequately treated, it can lead to
infertility and other sexual and reproductive health complications.
It also increases the risk of HIV infection.i
The safety and tolerability profile of gepotidacin in the EAGLE-1
phase III trial was consistent with results seen in
gepotidacin phase I and II trials.
Detailed results from the EAGLE-1 trial will be presented at an
upcoming scientific meeting and shared with global health
authorities.
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 Copenhagen in April 2023, and subsequently published
in The
Lancet.[iv] If
approved, gepotidacin could be the first in a new class of oral
antibiotics in uUTI in over 20 years.
The development of gepotidacin has been funded in whole or 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, 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 caused by Neisseria
gonorrhoeae.
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 current antibiotics. Due to the well-balanced
inhibition of two enzymes, gepotidacin target-specific mutations in
both enzymes are needed to affect susceptibility to gepotidacin
significantly.
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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Investor
Relations:
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Nick
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James
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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
2022, and Q4 Results for 2023.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[i] World
Health Organisation, Multi-drug resistant gonorrhoea. Available
at: https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea
[ii] CDC
data on file
[iii] CDC
Sexually Transmitted Infections Surveillance, 2022, available
at: https://www.cdc.gov/std/statistics/2022/default.htm#:~:text=In%202022%2C%20more%20than%202.5,from%20all%20STI%20prevention%20partners.
[iv] 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: February
26, 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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