REG - GSK PLC - US FDA Fast Track designation for bepirovirsen

GSKAnnouncement

12/02/2024 07:00

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RNS Number : 7116C  GSK PLC  12 February 2024

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.

 

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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.

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