GSK PLC on Monday said that the US health watchdog granted fast track designation for its bepirovirsen treatment for chronic hepatitis B.
The Brentford, London-based pharmaceutical company said that the process speeds up the development and review of a drug to ‘fill an unmet medical need.
GSK highlighted that the designation underlined the unmet need for medicines that can achieve function cure in patients with chronic hepatitis B.
‘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,’ GSK said.
Bepirovirsen is an oligonucleotide, which are short single- or double-stranded DNA or RNA molecules. Their main function is modulating gene and protein expression.
GSK explained: ‘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 in the blood, and stimulates the immune system to increase the chances of a durable and sustained response.’
GSK shares were 0.6% lower at 1,650.40 each on Monday morning in London.
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