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 January 2026
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(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: 7 January 2026,
London UK
GSK announces positive results from B-Well 1 and B-Well 2 phase III
trials for bepirovirsen, a potential first-in-class treatment for
chronic hepatitis B
● Primary endpoint met in both
trials
● Bepirovirsen demonstrated a statistically
significant and clinically meaningful functional cure
rate
●
Chronic hepatitis B
(CHB) accounts for ~56% of liver cancer cases[1] and
affects more than 250 million people worldwide[2]
● Global regulatory filings planned from Q1
2026
GSK plc (LSE/NYSE: GSK) today announced positive results from its
two pivotal phase III trials, B-Well 1 [NCT05630807] and B-Well 2
[NCT 05630820], evaluating bepirovirsen, an investigational
antisense oligonucleotide (ASO) for the treatment of chronic
hepatitis B (CHB) in over 1,800 patients from 29
countries.
CHB is a major health challenge affecting over 250 million people
worldwide and is the leading cause of liver cancer. The current
standard of care - nucleos(t)ide
analogues - often
requires lifelong therapy and the functional cure rates remain low,
typically only 1%.[3] Functional
cure for CHB is when the virus can no longer be detected in the
blood, as measured by the sustained loss of hepatitis B surface
antigen - a viral protein that signals ongoing infection - and
undetectable hepatitis B virus DNA for at least 24 weeks after a
finite course of treatment. This allows the immune system to
control the infection without further medication. Functional
cure is associated with significant reduction in the risk of
long-term liver complications, including liver cancer, as well as
all -cause mortality.[4], [5]
The B-Well trials met their primary endpoint, and bepirovirsen
demonstrated a statistically significant and clinically meaningful
functional cure rate. Functional cure rates were significantly
higher with bepirovirsen plus standard of care compared with
standard of care alone. Results were statistically significant across all
ranked endpoints, including in patients with baseline surface
antigen (HBsAg) <=1000 IU/ml where an even greater effect was
demonstrated. The trials
demonstrated an acceptable safety and tolerability profile
consistent with what was reported in other
studies.
Tony Wood, Chief Scientific Officer, GSK, said:
"Bepirovirsen has the potential to transform treatment goals for
people living with CHB by achieving significant functional cure
rates - a first for the disease. CHB affects more than 250 million
people and leads to approximately 56% of liver cancer cases
worldwide. Today's result supports our plans to progress
bepirovirsen as a treatment and also continue its development as a
backbone in future sequential therapies. We're pleased by this
major advance in our expanding hepatology pipeline, aimed to
transform outcomes in liver disease."
Full results will be submitted for presentation at an upcoming
scientific congress, published in a peer-reviewed journal and used
to support regulatory submissions to health authorities worldwide.
If approved, bepirovirsen has the potential to become the first
finite, six-month therapeutic option for CHB and to serve as a
backbone for future sequential treatment strategies.
Clinical trial programme
B-Well 1 and B-Well 2 trials are global multi-centre, randomised,
double-blind, placebo-controlled trials conducted in 29 countries.
They assessed the efficacy, safety, pharmacokinetic profile, and
the durability of functional cure in nucleos(t)ide analogue
(NA)-treated participants with CHB and baseline surface antigen
(HBsAg) ≤3000 IU/ml. The primary endpoint assessed the
proportion of participants achieving functional cure in patients
with baseline surface antigen (HBsAg) ≤3000 IU/ml. A key
ranked secondary endpoint evaluated functional cure in participants
with baseline HBsAg ≤1000 IU/ml. Functional cure is defined
as hepatitis B surface antigen (HBsAg) loss and undetectable HBV
DNA for at least 24 weeks after a finite course of
treatment.
About chronic hepatitis B
Hepatitis B is a viral infection that can cause both acute and
chronic liver disease. Chronic hepatitis B occurs when the immune
system is unable to clear the virus, resulting in long-lasting
infection that affects more than 250 million people worldwide. The
disease causes approximately 1.1 million deaths each
year[6],
and accounts for approximately 56% of liver cancer cases globally.
Many patients often require lifelong antiviral therapy for viral
suppression; making functional cure a critical goal in disease
management.
About bepirovirsen
Bepirovirsen is a triple action investigational antisense
oligonucleotide (ASO), designed to recognise and orchestrate the
destruction of 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.
GSK licensed bepirovirsen from Ionis and collaborated with them on
its development. Bepirovirsen has
been recognised by global regulatory authorities for its innovation
and potential to address significant unmet need in hepatitis B,
with Fast Track designation from the US FDA, Breakthrough Therapy
designation in China and SENKU designation in
Japan.
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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+44 (0)
20 8047 5502
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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
Alison
Hunt
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+1 202
603 5003
+1 540 742 3391
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(Washington
DC)
(Washington
DC)
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Investor
Relations:
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Constantin
Fest
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+44 (0)
7831 826525
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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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Steph
Mountifield
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+44 (0)
7796 707505
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(London)
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Sam
Piper
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+44 (0)
7824 525779
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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 3126
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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 in the "Risk Factors" section in GSK's
Annual Report on Form 20-F for 2024, and GSK's Q3 Results for
2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79 New Oxford
Street
London
WC1A
1DG
1 Rumgay
H et al . Global burden of primary liver cancer in 2020 and
predictions to 2040. J Hepatol. 2022;77:1598-1606. doi:
10.1016/j.jhep.2022.08.021
[2] WHO,
Global hepatitis report 2024. Available at: https://www.who.int/publications/i/item/9789240091672 (last
accessed: January 2026)
[3] 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" in GastroHep 2, 106-116 (2020)
[4] Drysdale
M et al. GHS 2025. Oral
presentation. Slides available upon request.
[5] EASL,
"Clinical Practice Guidelines on the management of hepatitis B
virus infection" in Journal
of Hepatology
Volume 83, Issue 2, August 2025, Pages
502-583. Available at: https://www.sciencedirect.com/science/article/pii/S0168827825001746 (last
accessed: January 2026)
[6] WHO.
Global hepatitis report 2024. Available
at: https://www.who.int/publications/i/item/9789240091672 (last
accessed: January 2026)
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: January
07, 2026
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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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