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 November 2022
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 . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 3 November 2022, London UK
EAGLE-2 and EAGLE-3 phase III trials for gepotidacin stopped early
for efficacy following pre-planned interim analysis by Independent
Data Monitoring Committee
●
Gepotidacin could be the
first new novel oral antibiotic
treatment for uncomplicated urinary tract
infections in over 20
years
●
GSK plans to submit a New Drug
Application for gepotidacin to the US Food and Drug Administration
(FDA) in H1 2023
GSK plc (LSE/NYSE: GSK) today announced that the pivotal phase III
EAGLE-2 and EAGLE-3 trials evaluating gepotidacin, an
investigational treatment for uncomplicated urinary tract infection
(uUTI) in female adults and adolescents, will stop enrolment early
for efficacy following a recommendation by the Independent Data
Monitoring Committee (IDMC). This decision was based on a
pre-specified interim analysis of efficacy and safety data in over
3000 patients across the trials.
Chris Corsico, SVP, Development, GSK, said: "Uncomplicated urinary tract infections (uUTI)
are the most common outpatient infection with over half of all
women developing a uUTI during their lifetime and more than a
quarter of women suffering from recurrent uUTIs. There has been no
new class of oral antibiotics for uUTI for over 20 years. With the
number of uUTIs caused by resistance bacteria increasing, new
antibiotic treatments are necessary. The IDMC's recommendation to
stop the EAGLE-2 and 3 trials early for efficacy provides GSK with
the opportunity to engage regulatory authorities as we work
together to bring a new class of antibiotics to patients with
uUTIs."
The EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint of
combined clinical and microbiological resolution following
treatment at the Test-Of-Cure (TOC) visit for gepotidacin versus
nitrofurantoin in patients with a confirmed uUTI and a uropathogen
sensitive to nitrofurantoin. The IDMC review did not identify any
safety concerns.
The EAGLE-2 and 3 trials are now closed for recruitment, with final
study visits and data collection anticipated during the first
quarter of 2023. GSK will work with regulatory authorities to
commence regulatory filings for gepotidacin in H1 2023. The
full results will also be submitted for presentation at a
scientific congress and for publication in a peer-reviewed journal
in 2023.
The development of gepotidacin is the result of a public-private
partnership between GSK, the US government's Biomedical Advanced
Research and Development Authority (BARDA), part of the
Administration for Strategic Preparedness and Response at the U.S.
Department of Health and Human Services, and Defense Threat
Reduction Agency (DTRA) within the Department of Defense. The
collaboration with BARDA was established in 2013 with the aim to
support the development of antibiotics to fight antibiotic
resistance and bioterrorism under
contract number HHSO100201300011C.
uUTIs are one of the most common infections in the
community1.
The annual incidence of uUTI (or acute cystitis) in women is 12%
and c.˜20% in women over 65; 30-44% of uUTI episodes are
recurrent[1],[2],[3]. Escherichia
coli (e.
coli) bacteria
are the main cause of uUTI1 but
it is showing increasing resistance to antibiotics currently
used[4],[5],
leaving healthcare professionals with fewer oral options to treat
their patients[6].
As a result, there is a need to develop new oral antibiotics that
may help treat uUTIs and potentially combat antimicrobial
resistance (AMR) in the community, particularly given that there
has not been a new class of oral antibiotics for uUTI for over 20
years.2,[7]
About the EAGLE (Efficacy of Antibacterial Gepotidacin Evaluated)
phase III programme
The phase III clinical programme for gepotidacin in adults and
adolescents comprises three trials:
●
|
EAGLE-2 (non-inferiority
uUTI trial, 204989) compares the efficacy and safety of gepotidacin
(1500mg administered orally twice daily for 5 days) to
nitrofurantoin (100mg administered orally twice daily for five
days). The trial duration for participants is approximately 28
days. The primary endpoint is the combined clinical and
microbiological response at the TOC visit in patients with
qualifying uropathogens.
|
●
|
EAGLE-3 (non-inferiority
uUTI trial, 212390) compares the efficacy and safety of gepotidacin
(1500mg administered orally twice daily for 5 days) to
nitrofurantoin (100mg administered orally twice daily for 5 days).
The trial duration for participants is approximately 28 days up
until follow-up. The primary endpoint is the combined clinical and
microbiological response at the TOC visit in patients with
qualifying uropathogens.
|
●
|
EAGLE-1 (non-inferiority
urogenital gonorrhoea trial, BTZ116577) compares the efficacy and
safety of gepotidacin (3000mg administered orally at the trial site
during the baseline visit followed by self-administration of a
second oral 3000mg dose as an outpatient 10 to 12 hours after the
first dose) to a single intramuscular 500mg dose of ceftriaxone
plus a single oral 1g dose of azithromycin in approximately 600
patients with uncomplicated GC caused by the bacterium NG. The
trial duration is approximately 21 days. At the TOC visit, the
primary endpoint is the culture-confirmed bacterial eradication of
NG from the urogenital body site. The EAGLE-1 trial which is
investigating gepotidacin for the treatment of uncomplicated
urogenital gonorrhoea is ongoing.
|
EAGLE-2 and 3 are similar trials and together provide substantial
clinical evidence, with EAGLE-2 providing additional
pharmacokinetic data and EAGLE-3 including an on-treatment ECG
test. Trial enrolment overlapped with the COVID-19 pandemic
(the EAGLE-2 trial started in October 2019, and the EAGLE-3 trial
began in May 2020), and trial sites are located across 12
countries, each with different infection and resistance
patterns.
About gepotidacin
Gepotidacin is a novel, investigational bactericidal,
first-in-class triazaacenaphthylene antibiotic that inhibits
bacterial DNA replication by a distinct mechanism of
action[8],[9] and
equally and independently binds to two different Type II
topoisomerase enzymes[10].
This provides activity against most strains of E. coli and S.
saprophyticus, including isolates resistant to current
antibiotics[11],[12].
Due to the equal and independent binding at both enzymes, mutations
in both enzymes are needed to significantly affect gepotidacin
susceptibility.
GSK in antibiotics
GSK has been developing and supplying antibiotics for more than 70
years. Research and development continue to investigate new tools
to prevent and mitigate infectious disease - and get ahead of
antimicrobial resistance. GSK is already a leader on the
Antimicrobial Resistance Benchmark of the Access to Medicine
Foundation. In September 2022, GSK entered into an exclusive
licence agreement with Spero Therapeutics to add a late-stage
antibiotic, tebipenem HBr for the potential treatment of
complicated urinary tract infections (cUTI), to our
pipeline. The
closing of the transaction is subject to the expiration of the
waiting period under the Hart-Scott-Rodino Antitrust Improvements
Act of 1976, as amended.
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/company
GSK enquiries
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Media:
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Tim
Foley
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Dan
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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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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)
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(London)
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Jeff
McLaughlin
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Frannie
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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 in the Company's
Annual Report on Form 20-F for 2021, GSK's Q3 Results for 2022 and
any impacts of the COVID-19 pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[1] Hooton
TM. Uncomplicated Urinary Tract Infection. N Engl J Med.
2012;366:1028-37.
[2] Rich
SN, Klann EM, Almond CR, Larkin EM, Nicolette G, Ball JD.
Associations between antibiotic prescriptions and recurrent urinary
tract infections in female college students. Epidemiology and
Infection. 2019;147.
[3] Medina
M, Castillo-Pino E. An introduction to the epidemiology and burden
of urinary tract infections. Therapeutic Advances in Urology.
2019;11:175628721983217.
[4] WHO.
Global priority list of antibiotic-resistant bacteria to guide
research, discovery, and development of new antibiotics.
2017.
[5] CDC.
Antibiotic resistance threats in the United States. 2019. Available
from: https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf [Accessed
October 2022]
[6] Kaye
KS, et al. Clin Infect Dis.
2021;73(11):1992-1999
[7] 2020
Antibacterial agents in clinical and preclinical development: an
overview and analysis. Geneva: World Health Organization; 2021.
Licence: CC BY-NC-SA 3.0 IGO.
[8] Gibson
EG, et
al. ACS Infect
Dis 2019;5(4):570−581
[9] Bax
BD, et al.
Nature 2010;466(7309):935-940.
[10] Oviatt
A, et
al. Poster
#L0178 presented at ECCMID, 23-26 Apr, 2022, Lisbon,
Portugal.
[11] Biedenbach
DJ, et
al. Antimicrob
Agents Chemother 2016;60(3):1918-1923
[12] Mushtaq
S, et
al. Poster
#P1849 presented at ECCMID, 13-16 April, 2019, Amsterdam, The
Netherlands.
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: November
03, 2022
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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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