REG - GSK PLC - GSK announces positive EAGLE-1 headline results

GSKAnnouncement

26/02/2024 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240226:nRSZ3314Ea&default-theme=true

RNS Number : 3314E  GSK PLC  26 February 2024

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  (#_edn1) In the United States, rates of reported
gonorrhoea have increased 118% from 2009 to 2021 ii  (#_edn2) , with 648,056
cases being reported to the US Centers for Disease Control and Prevention
(CDC) in 2022. iii  (#_edn3) 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 Lan
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02196-7/abstract)
cet
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02196-7/abstract)
. iv  (#_edn4) 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
 Media:               Tim Foley          +44 (0) 20 8047 5502  (London)
                      Sarah Clements     +44 (0) 20 8047 5502  (London)
                      Kathleen Quinn     +1 202 603 5003       (Washington DC)
                      Lyndsay Meyer      +1 202 302 4595       (Washington DC)

 Investor Relations:  Nick Stone         +44 (0) 7717 618834   (London)
                      James Dodwell      +44 (0) 20 8047 2406  (London)
                      Mick Readey        +44 (0) 7990 339653   (London)
                      Josh Williams      +44 (0) 7385 415719   (London)
                      Camilla Campbell   +44 (0) 7803 050238   (London)
                      Steph Mountifield  +44 (0) 7796 707505   (London)
                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco   +1 215 751 4855       (Philadelphia)

 

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  (#_ednref1) World Health Organisation, Multi-drug resistant gonorrhoea.
Available at:
https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea
(https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea)

 ii  (#_ednref2) CDC data on file

 iii  (#_ednref3) 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
(https://www.cdc.gov/std/statistics/2022/default.htm#:~:text=In%202022%2C%20more%20than%202.5,from%20all%20STI%20prevention%20partners)
.

 iv  (#_ednref4) 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
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02196-7/abstract)

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCFLFEEFAIVFIS