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
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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.
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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.