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 August 2024
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 . . . . . . . .
GSK plc (the
'Company')
Transaction notification
Issued: 28 August 2024,
London UK
Bepirovirsen granted SENKU designation in Japan for chronic
hepatitis B
● Designation expedites review of bepirovirsen as a
potential treatment for people living with chronic hepatitis B
(CHB)
●
Designation
based on strength of data from the B-Clear
and B-Sure trials and
need for innovative medicines to achieve functional
cure
●
SENKU
follows US FDA Fast Track designation earlier this
year
GSK plc (LSE/NYSE: GSK) today announced that the Japanese Ministry
of Health, Labour and Welfare (MHLW) has granted SENKU (formerly
known as SAKIGAKE) designation for bepirovirsen, an investigational
antisense oligonucleotide (ASO) for the treatment of chronic
hepatitis B (CHB). SENKU designation is granted based on the level
of innovation, severity of disease, and prominent efficacy. The
goal of SENKU designation is to increase early patient access to
innovative medicines through an expedited review process to treat
serious conditions and fill an unmet medical need.
The designation is based on results from the phase IIb B-Clear and
B-Sure trials1,2 which
evaluated the efficacy, safety and durability of response of
bepirovirsen in people with CHB. A confirmatory phase III
programme, B-Well, is ongoing. This is the second regulatory
designation in 2024 for bepirovirsen, following the US Food and
Drug Administration (FDA) Fast Track designation for bepirovirsen
granted earlier this year. Further information is available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-fast-track-designation-for-bepirovirsen-in-chronic-hepatitis-b.
CHB affects 257 million people worldwide, and nearly 1 million
people in Japan.3 Current
treatment options provide a functional cure rate of less than 2-8%
for pegylated interferon (PegIFN) and less than 1% for oral
treatments (nucleoside/nucleotide analogues
[NAs]).4 Functional
cure occurs when the hepatitis B virus DNA and viral protein,
hepatitis B surface antigen (HBsAg), are at levels low enough to be
undetectable in the blood and can be controlled by the immune
system without medication. Current therapies only suppress the
virus and do not directly lower HBsAg, which is essential for
functional cure.
Bepirovirsen is the only single agent in phase III development that
has shown the potential to achieve clinically meaningful functional
cure response when combined with oral NAs. Bepirovirsen is also
being investigated as a potential backbone therapy in future
sequential regimens to pursue functional cure in a broader
population of patients with CHB.
About the B-Clear and B-Sure phase IIb trials
The B-Clear trial consisted of two parallel cohorts, one for
patients receiving NA treatment and the other for patients who were
not-on-NA. Further information is available at:
https://www.nejm.org/doi/full/10.1056/NEJMoa2210027.
Longer term efficacy and durability of response is being
investigated in the B-Sure trial, which follows participants from
the B-Clear study for an additional 33 months and includes criteria
for stopping NA therapy to evaluate the potential for functional
cure in patients who successfully stop all medication and continue
to demonstrate no serologic evidence of hepatitis B surface antigen
(HBsAg) or HBV DNA.
About B-Well 1 and B-Well 2 phase III trials
These
two multi-centre, randomised, double-blind, placebo-controlled
phase III trials (B-Well 1 and B-Well 2) assess the efficacy,
safety, pharmacokinetic profile, and the durability of hepatitis B
virus surface antigen (HBsAg) suppression with bepirovirsen
treatment in nucleos(t)ide analogue (NA)-treated participants with
chronic hepatitis B and baseline HBsAg <=3000 IU/ml. The primary
endpoint of the trials is the number of participants achieving
functional cure with baseline HBsAg ≤3000 IU/mL.
Further information is available on CT.gov at https://clinicaltrials.gov/study/NCT05630807 and https://clinicaltrials.gov/study/NCT05630820.
About CHB
Hepatitis B is a viral infection of the liver, caused by the
hepatitis B virus, that can cause both acute and chronic liver
disease.5 Chronic
hepatitis B (CHB) is a long-lasting infection and occurs when the
body's immune system is unable to fight off the virus and it
persists in the blood and liver.5 CHB
is a major global health issue, affecting 257 million people across
the world,3 although
only about 13% of these people have a diagnosis and only 3% receive
treatment.6 CHB
can progress to more serious conditions like cirrhosis and liver
cancer, and more than a million people die from this infection
every year.
About bepirovirsen (GSK3228836)
Bepirovirsen is a triple action investigational antisense
oligonucleotide (ASO), currently being evaluated in the B-Well
phase III clinical trial programme for the treatment of CHB.
Bepirovirsen is designed to recognise and destroy the genetic
components (i.e. RNA) of the hepatitis B virus that can lead to
chronic disease, potentially allowing a person's immune system to
regain control. Bepirovirsen inhibits the replication of viral DNA
in the body, suppresses the level of hepatitis B surface antigen
(HBsAg) in the blood, and stimulates the immune system to increase
the chances of a durable and sustained response.
Bepirovirsen (previously known as 'ISIS 505358 or IONIS-HBVRX') was
discovered by and jointly developed with Ionis Pharmaceuticals.
Bepirovirsen is one of the ASO HBV programme assets in-licensed by
GSK from Ionis Pharmaceuticals in August 2019.
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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GSK enquiries
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Media:
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Tim Foley
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(London)
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Sarah Clements
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+44 (0) 20 8047 5502
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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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+1 202 302 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) 7385 415719
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(London)
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Camilla Campbell
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+44 (0) 7803 050238
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(London)
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Steph Mountifield
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+44 (0) 7796 707505
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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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 GSK's Annual Report on Form 20-F for 2023, and
GSK's Q2 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1 Yuen
M-F, Lim S-G, Plesniak R, et al. Efficacy and safety of
bepirovirsen in chronic hepatitis B infection. N Engl J Med.
2022;387(21):1957-68.
2
Gadano et al. EASL 2023 Abstract 4132
3 Polaris Observatory
Collaborators. Lancet
Gastroenterol Hepatol 2023;8(10):879-907
4 Slaets, L. et
al. Systematic
review with meta-analysis: hepatitis B surface antigen decline and
seroclearance in chronic hepatitis B patients on nucleos(t)ide
analogues or pegylated interferon therapy GastroHep 2, 106-116
(2020)
5
World Health Organisation. Hepatitis B Key Facts, January
2023
6
World Health Organization. Global Hepatitis Report 2024 WHO
(2024).
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: August
28, 2024
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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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