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.
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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.
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