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 June 2023
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: 27 June, London UK
GSK receives US FDA Fast Track designation for investigational
vaccine against gonorrhoea
● Fast Track designation accelerates the vaccine
candidate's path to US FDA submission for the prevention
of Neisseria
gonorrhoeae infection
●
Gonorrhoea is the
second most prevalent bacterial sexually transmitted infection
worldwide with an estimated 82
million new cases globally each year[1],[2]
●
Currently there are
no vaccines approved anywhere in the world for gonorrhoea, and
antimicrobial resistance to existing treatments is
increasing2
GSK plc (LSE/NYSE: GSK) announced today the US Food and Drug
Administration (FDA) has granted a Fast Track designation for
its Neisseria
gonorrhoeae investigational vaccine (NgG). The vaccine
candidate is currently in an ongoing Phase II trial and aims to
demonstrate proof of concept by assessing the efficacy of the NgG
vaccine in healthy adults, 18 to 50 years of age, considered at
risk of gonorrhoea. Fast Track designation is intended to
facilitate the development and expedite the review of potentially
important new drugs and vaccines to treat or prevent serious
conditions with unmet medical needs.
Gonorrhoea is the second most prevalent bacterial sexually
transmitted infection (STI) worldwide1, with an estimated 82
million new cases globally each year.2 In the US, rates of reported gonorrhoea have
increased 118% from 2009 to 2021, resulting in 710,151 cases being
reported to the US Centers for Disease Control and Prevention (CDC)
in 2021.[3]
Phil Dormitzer, Global Head of Vaccines R&D, GSK,
said: "We welcome the FDA's decision to grant Fast Track
designation for our new vaccine candidate
against Neisseria
gonorrhoeae infection. With a high and
growing incidence, gonorrhoea is a major concern for sexual and
reproductive health around the globe. This designation recognises
the potential for a vaccine that could help protect millions of
people across the world against the serious health consequences of
infection with a bacterium that is considered a 'high priority'
pathogen by the World Health Organisation."
Antimicrobial resistance (AMR)
to gonorrhoea has increased over the past 80 years, rendering many
classes of antibiotics used to treat the disease
ineffective.2 Vaccines can play a critical role in the fight
against AMR by helping prevent bacterial, viral and other
infections. At this time, there are no gonorrhoea vaccines approved
anywhere in the world.[4]
About the Phase I/II trial
The trial conducted by GSK is a Phase I/II first time in human
study (FTiH) evaluating the vaccine candidate's safety and efficacy
in individuals aged 18-50 years old, regardless of previous
gonorrhoea history. Phase I of the study was a FTiH dose-escalation
safety lead-in conducted in healthy adults and is now complete.
Phase II of the study is ongoing and aims to demonstrate Proof of
Concept by assessing the efficacy of the NgG vaccine in healthy
adults considered at risk of gonorrhoea. The trial started in
November 2022, and approximately 750 subjects will be enrolled from
8 countries (US, UK, France, Germany, Spain, Brazil, Philippines,
South Africa).
About Gonorrhoea
Gonorrhoea is a sexually transmitted infection (STI) caused by a
bacterium called Neisseria
gonorrhoeae (Ng). It is recognised as
an urgent unmet medical need due to its growing global incidence
and reduced efficacy of available treatments as drug-resistant
strains are increasing.2 Ng
infection in women is often asymptomatic and under-diagnosed. When
left untreated, Ng infection
can lead to complications and long-term consequences such as pelvic
inflammatory disease, infertility, ectopic pregnancy, and adverse
pregnancy outcomes.4 Painful symptoms in men make gonorrhoea more
likely to be diagnosed,[5] but
stigma surrounding the disease is still a barrier to seeking
diagnosis and treatment. It has also been shown that Ng infections
may also increase the risks of acquiring or transmitting
HIV.5,[6]
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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+44 (0)
20 8047 5502
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(London)
|
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Simon
Moore / Dan Smith
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+44 (0)
20 8047 5502
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(London)
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Alison
Hunt
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+1 540
742 3391
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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
|
+44 (0)
20 8047 2406
|
(London)
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Mick
Readey
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+44 (0)
7990 339653
|
(London)
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Josh
Williams
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+44 (0)
7385 415719
|
(London)
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Camilla
Campbell
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+44
(0) 7803
050238
|
(London)
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Steph
Mountifield
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+44 (0)
7796 707505
|
(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
|
|
Frannie
DeFranco
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+1 215
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 under Item 3.D
'Risk factors" in the company's Annual Report on Form 20-F for
2022, and Q1 Results for 2023 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
[1]. Rowley et al. Chlamydia, gonorrhoea, trichomoniasis and
syphilis: global prevalence and incidence estimates, 2016. Bull
World Health Organ. 2019 1;97(8):548-562. doi:
10.2471/BLT.18.228486.
[2]. WHO. Multi-drug resistant gonorrhoea. Available at:
https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea2022. Accessed
June 2023.
[3]. CDC. Sexually Transmitted Disease Surveillance. Available at:
https://www.cdc.gov/std/statistics/2021/figures.htm. Accessed June
2023.
[4]. Gottlieb S et al. Gonococcal vaccines: Public health
value and preferred product characteristics; report of a WHO global
stakeholder
[5]. Fleming DT et al. From epidemiological synergy to public
health policy and practice: the contribution of other sexually
transmitted diseases to sexual transmission of HIV infection. Sex
Transm Infect. 1999 75(1)3-17. doi:
10.1136/sti.75.1.3.
[6]. Bernstein K et al. Rectal gonorrhoea and chlamydia
reinfection is associated with increased risk of HIV
seroconversion. J Acquir Immune Defic Syndr. 2010
1;53(4):537-43. doi:
10.1097/QAI.0b013e3181c3ef29.
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: June
27, 2023
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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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