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 February 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 . . . . . . . .
Issued: 12 February 2024, London UK
GSK receives US FDA Fast Track designation for bepirovirsen in
chronic hepatitis B
●
Designation underscores
the unmet
need for medicines that can achieve functional cure in patients
with chronic hepatitis B (CHB)
GSK plc (LSE/NYSE: GSK) announced
today that the US Food and Drug Administration (FDA) has granted
Fast Track designation for bepirovirsen, an investigational
antisense oligonucleotide (ASO) for the treatment of chronic
hepatitis B (CHB). Fast track designation is intended to
facilitate the development and expedite the review of drugs to
treat serious conditions and fill an unmet medical
need.
The designation was requested based on the potential for
bepirovirsen to address an unmet medical need for CHB, a serious
and life-threatening condition. Data from the phase IIb trials
B-Clear and B-Sure, which evaluated the efficacy, safety and
durability of response of bepirovirsen in people with CHB, were
submitted in support of the application. A confirmatory phase III
programme, B-Well, is ongoing.
CHB affects nearly 300 million people worldwide,1 and
current treatment options offer a less than 2-8% functional cure
rate which is not clinically meaningful.2 Functional
cure occurs
when the hepatitis B virus DNA and viral proteins are at levels low
enough to be undetectable in the blood and can be controlled by the
immune system without medication. Currently available oral
antiviral therapies - called nucleoside/nucleotide analogues (NAs)
- only suppress the virus and do not directly lower hepatitis B
surface antigen (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 nucleoside/nucleotide
analogues (NAs). This was demonstrated by positive results in the
B-Clear and B-Sure clinical trials.3,4 B-Clear
identified that patients with low baseline hepatitis B surface
antigen levels are most likely to benefit from treatment with
bepirovirsen. 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 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.1 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.1 CHB
is a major global health issue, affecting nearly 300 million people
across the world, although only about 10% of these people have a
diagnosis and only 5% receive treatment.5 Even
when treated, CHB can progress to liver complications including
cirrhosis and liver cancer, which results in almost a million
deaths per year.6,7
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.
GSK enquiries
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Media:
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Meyer
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Investor
Relations:
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Nick
Stone
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(London)
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James
Dodwell
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+44 (0)
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Steph
Mountifield
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Frannie
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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.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
References
1 World Health Organisation. Hepatitis B Key Facts, January
2023
2 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.
2020;2(3):106-116.
3 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.
4 Gadano
et al. EASL 2023 Abstract 4132
5 Polaris Observatory Collaborators. Global prevalence, treatment,
and prevention of hepatitis B virus infection in 2016: a modelling
study. Lancet Gastroentero Hepatol. 2018
Jun;3(6):383-403.
6 Lok AS et al. Antiviral therapy for chronic hepatitis B viral
infection in adults: A systematic review and meta-analysis.
Hepatology. 2016;63:284-306.
7 Polaris estimate.
https://cdafound.org/polaris-regions-dashboard/. Last accessed 3
Jan 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: February
12, 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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