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.
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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.
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