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 May 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: 28 May 2026, London UK
Bepirovirsen achieves unprecedented functional cure rates with
potential to redefine treatment for chronic hepatitis
B
●
Pivotal B-Well data show a significant 19% functional cure in the
overall study population and 26% in patients with lower viral
activity compared to 0% with standard of care
only[1]
●
49% of bepirovirsen recipients achieved a surface antigen level of
≤100 IU/mL one year after end of treatment in exploratory
analysis
●
Over 240
million people worldwide live with chronic hepatitis
B[3]
GSK plc (LSE/NYSE: GSK) today announced positive pivotal data for
bepirovirsen, its investigational antisense oligonucleotide (ASO)
for the treatment of chronic hepatitis B (CHB). Results from the two phase III trials,
B-Well 1 [NCT05630807] and B-Well 2 [NCT05630820], were
simultaneously published in the New England Journal of
Medicine and presented at
the European Association for the Study of the Liver (EASL)
congress.1
Pooled data from both trials showed that 6-month treatment with
bepirovirsen achieved a statistically significant and clinically
meaningful 19% functional cure response rate (233 of 1,220 vs. 0 of
614 in the placebo group[i],
with p<0.001
in both trials) in the overall study population (adults
with ≤3000
IU/ml hepatitis B surface antigen (HBsAg) level), meeting the
primary endpoints. In a key secondary endpoint, a functional cure
rate of 26% (200 of 768 vs. 0 of 393 in the placebo group,
with p<0.001
in both trials) was achieved in participants
with ≤1000
IU/ml HBsAg level, a group that represents approximately 45% of
diagnosed CHB cases globally.[4] The
current standard of care typically requires lifelong therapy, with
functional cure rates achieved in less than 1% of
patients.[5]
Functional cure occurs when the hepatitis B virus (HBV) DNA and
HBsAg are undetectable in the blood for at least 6 months after
stopping all treatment. This indicates the disease is controlled by
the immune system without medication.[6] A
loss in HBsAg is also associated with an 89% reduction in risk of
liver cancer and a 62% reduction in risk of all-cause
mortality.2 Notably,
in an exploratory analysis, 49% of bepirovirsen
recipients achieved a quantitative hepatitis B surface antigen
(qHBsAg) of ≤100 IU/mL one year after the end of treatment.
Medical literature has linked this level of low surface antigen
with increased immune control and improved patient
outcomes.[7] Moreover,
23% of all bepirovirsen recipients (283 of 1220 vs 0 of
614 in
the placebo group; p<0.001 in both trials) and 31% of
bepirovirsen recipients with baseline HBsAg ≤1000 IU/mL (237
of 768 vs 0 of 393 in the placebo group; p<0.001 in both
trials) achieved
a sustained HBV DNA lower limit of quantification (<LLOQ) at
week 72 after stopping all treatment at week 48 in a key secondary
endpoint.
The trials showed an acceptable safety and tolerability profile
consistent with other studies of bepirovirsen. The three most
frequently observed adverse events were injection site erythema,
local pain and temporary rise in the blood level of a liver
enzyme.
Tony Wood, Chief Scientific Officer, GSK, said:
"CHB affects over 240 million people worldwide3 and
accounts for over half of global liver cancer
cases.[8] For
the first time, bepirovirsen offers the possibility of
significantly better functional cure rates than the current
standard of care, and the potential to reduce the risk of long-term
liver complications, including cancer. This is a major step forward
in our growing pipeline to treat liver disease to help transform
outcomes for patients."
Efforts around testing, diagnosis and treatment of CHB are
increasingly underway in multiple geographies, including
China[9] and
the US[10],
with clinical guidelines striving for functional cure as a
treatment goal.
Professor Jinlin Hou, Director of Guangdong Institute of
Hepatology, China, and lead author of the New England
Journal of Medicine's
manuscript, said:
"Today's standard of care for CHB imposes a heavy burden on
patients and healthcare systems, and rarely delivers a functional
cure. With recent guidelines now prioritising functional
cure6,
these new data could represent an important
advance. Combined
with improved testing and diagnosis, this innovation has the
potential to improve the lives of millions living with
CHB."
Results from the two trials are summarised in Table 1.
Table 1: Functional cure rate at Week 72 in B-Well 1 and B-Well 2
by patient segment
|
Endpoint
|
Patients with baseline HBsAg ≤ 3000 U/mL
|
Patients with baseline HBsAg ≤ 1000 IU/mL
|
|
FC response rate[ii] at
Week 72, 6 months after discontinuing all
treatments
|
Primary confirmatory endpoint[iii]
19% vs. 0% (placebo)
233 of 1,220 vs. 0 of 614
B-Well 1: 20% vs. 0%
[127 of 650 vs. 0 of 328]
B-Well 2: 19% vs. 0%
[106 of 570 vs. 0 of 286]
|
Ranked secondary endpoint
26% vs. 0% (placebo)
200 of 768 vs. 0 of 393
B-Well 1: 25% vs. 0%
[105 of 426 vs. 0 of 214]
B-Well 2: 28% vs. 0%
[95 of 342 vs. 0 of 179]
|
Bepirovirsen is currently under priority review by
the US Food and Drug Administration (FDA) with both Breakthrough
and Fast Track Designation.[11],[12] It
is also under review by regulatory authorities in
Europe[13], Japan with
SENKU designation[14] and
China with Breakthrough Therapy and Priority
Review designation.[15] GSK
anticipates the first regulatory decisions in Q3 2026
and launch
preparations are underway. In May 2026, GSK entered a strategic
collaboration with Sino
Biopharmaceutical that aims to accelerate patient access to
bepirovirsen at launch in China.[16]
About the B-Well 1 and B-Well 2 clinical trials
The 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 durability of functional cure in nucleos(t)ide
analogue-treated adult participants with chronic hepatitis B and
baseline surface antigen (HBsAg) ≤3000 IU/ml. The primary
endpoint assessed the proportion of participants achieving
functional cure in patients with baseline 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 HBsAg being undetectable in the blood for at least 24
weeks after stopping all treatment, indicating that the disease is
controlled by the immune system without medication.
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 240 million people
worldwide, including 1.7
million people in the United States (US) and 75 million in
China.3 The
disease causes approximately 1.1 million deaths each
year3, and
accounts for approximately 56% of liver cancer cases globally.
Currently, many patients often require lifelong antiviral therapy
for viral suppression, making functional cure a critical goal in
disease management.
About bepirovirsen
Bepirovirsen is an investigational antisense oligonucleotide (ASO)
designed to recognize and inhibit the production 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 reduces the production of RNA and
viral proteins associated with HBV, 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 and
Breakthrough Designations from the US FDA, Breakthrough Therapy and
Priority Review designation in China and SENKU designation in
Japan.
About GSK's hepatology portfolio
GSK is extending its expertise in inflammation to develop a next
wave of innovation for the millions of people affected by chronic
and life-threatening fibro-inflammatory liver conditions. GSK has a
growing hepatology pipeline, harnessed by the science of the immune
system and advanced technologies, with a focus on chronic hepatitis
B and advanced steatotic liver disease (SLD), including metabolic
dysfunction-associated steatohepatitis (MASH) and
alcohol-associated liver disease (ALD).
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 www.gsk.com.
|
GSK enquiries
|
|
|
|
|
Media:
|
Tim Foley
|
+44 (0) 20 8047 5502
|
(London)
|
|
|
Simon Moore
|
+44 (0) 20 8047 5502
|
(London)
|
|
|
Kathleen Quinn
|
+1 202 603 5003
|
(Washington DC)
|
|
|
Alison Hunt
|
+1 540 742 3391
|
(Washington DC)
|
|
|
|
|
|
|
Investor Relations:
|
Constantin Fest
|
+44 (0) 7831 826525
|
(London)
|
|
|
James Dodwell
|
+44 (0) 20 8047 2406
|
(London)
|
|
|
Mick Readey
|
+44 (0) 7990 339653
|
(London)
|
|
|
Steph Mountifield
|
+44 (0) 7796 707505
|
(London)
|
|
|
Sam Piper
|
+44 (0) 7824 525779
|
(London)
|
|
|
Jeff McLaughlin
|
+1 215 751 7002
|
(Philadelphia)
|
|
|
Frannie DeFranco
|
+1 215 751 3126
|
(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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2025, and
GSK's Q1 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
[i] Bepirovirsen
arm received bepirovirsen plus standard of care, placebo arm
received placebo plus standard of care
[ii] Defined
as HBsAg not detected (qualitative; < 0.05 IU/mL) and HBV DNA
< LLOQ (< 20 IU/mL or target not
detected)
[iii] The
absolute values are being presented bepirovirsen group vs placebo
group.
[1] Hou
JL, Lim SG, Buti M, et
al. Phase
3 results of bepirovirsen treatment for chronic hepatitis B virus
infection" in New England
Journal of Medicine, May 2026. DOI:
10.1056/NEJMoa2515131; Seng-Gee Lim et al, "Clinically meaningful
rates of functional cure in virologically suppressed patients with
chronic hepatitis B infection treated with bepirovirsen: B-Well
Phase 3 Trials" - presentation at EASL, 28 May 2026. List of
accepted abstracts, available here: https://www.easlcongress.eu/wp-content/uploads/2026/03/List-of-accepted-regular-abstracts.pdf?utm (last
accessed May 2026)
[2] Drysdale
M. et al, "Association of Hepatitis B Surface Antigen Loss with
Long-Term Clinical Outcomes among Patients with Chronic Hepatitis B
Infection: A US Based Retrospective Cohort Study Using Optum
Electronic Health Records Database" in Z
Gastroenterol 2025; 63(08): e481, DOI:
10.1055/s-0045-1810830
[3] WHO,
Global hepatitis report 2026, April 2026
[4] GSK
data on file, 2026
[5] 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)
[6] 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: May 2026).
[7] Kim,
J.H., et
al. "Circulating serum HBsAg
level is a biomarker for HBV-specific T and B cell responses in
chronic hepatitis B patients. Sci
Rep 10,
1835 (2020).
https://doi.org/10.1038/s41598-020-58870-2"
[8] Rumgay
H et al. "Global
burden of primary liver cancer in 2020 and predictions to 2040",
in J
Hepatol.
2022;77:1598-1606. doi:
10.1016/j.jhep.2022.08.021
[9] National
Disease Control and Prevention Administration, National action plan
for the prevention and control of viral hepatitis (2025-2030),
available at: https://www.ndcpa.gov.cn/jbkzzx/c100014/common/content/content_1966406073307271168.html (last
accessed: May 2026)
[10] Ghany
M. et al, "AASLD IDSA Practice Guideline on treatment of chronic
hepatitis B", in Hepatology 83(4):p
974-997, April 2026.
DOI: 10.1097/HEP.0000000000001549
[11] GSK
press release, GSK receives US FDA Fast Track designation for
bepirovirsen in chronic hepatitis B, 12 February 2024. Available
at:
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-fast-track-designation-for-bepirovirsen-in-chronic-hepatitis-b
(last accessed: May 2026)
[12] GSK
press release, Bepirovirsen accepted for regulatory review and
granted Breakthrough Therapy Designation by the US FDA, 27 April
2026. Available at: https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-priority-review-and-granted-breakthrough-therapy-designation-by-the-us-fda/ (last
accessed: May 2026)
[13] GSK
press release, Bepirovirsen accepted for review by the European
Medicines Agency as a potential first-in-class treatment for
chronic hepatitis B, 27 March 2026. Available
at: https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-review-by-the-european-medicines-agency-as-a-potential-first-in-class-treatment-for-chronic-hepatitis-b/ (last
accessed: May 2026)
[14] GSK
press release, Bepirovirsen accepted for regulatory review in Japan
as a potential first-in-class treatment for chronic hepatitis B, 26
February 202. Available at:
https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-regulatory-review-in-japan/
(last accessed: May 2026)
[15] GSK
press release, Bepirovirsen accepted for regulatory review in China
as a potential first-in-class functional cure for chronic hepatitis
B, 30 March 2026. Available at: https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-regulatory-review-in-china-as-a-potential-first-in-class-functional-cure-for-chronic-hepatitis-b/ (last
accessed May 2026)
[16] GSK
press release, GSK enters exclusive collaboration with SBP Group, a
market leader in hepatology in China, to accelerate bepirovirsen at
launch, May 2026 - Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-enters-exclusive-collaboration-with-sbp-group-a-market-leader-in-hepatology-in-china-to-accelerate-bepirovirsen-at-launch/
(last accessed: May 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.
|
|
GSK plc
|
|
|
(Registrant)
|
|
|
|
|
Date: May
28, 2026
|
|
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GSK plc
|