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GSK granted US fast track status for chronic hepatits B treatment

Published 12/02/2024, 07:48
Updated 12/02/2024, 07:48
© Reuters.  GSK granted US fast track status for chronic hepatits B treatment

Proactive Investors - GSK (LON:GSK) has been granted US Fast Track designation for bepirovirsen, an investigational treatment for chronic hepatitis B (CHB).

A request was made to US regulator the FDA by the UK pharma due to an unmet medical for what is a serious and life-threatening condition, said the statement.

CHB affects nearly 300 million people worldwide, GSK added and current treatment options offer a less than clinically meaningful 2-8% functional cure rate.

"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)," it added.

Explaining, GSK said the treatment 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.

Data from phase IIb trials B-Clear and B-Sure in support of the efficacy, safety and durability of the response of bepirovirsen in people with CHB, were submitted with the application.

A confirmatory phase III programme, B-Well, is ongoing.

Bepirovirsen is one of the ASO HBV programme assets in-licensed by GSK from Ionis Pharmaceuticals (NASDAQ:IONS) in August 2019, with the therapy discovered and developed jointly by the two companies.

Read more on Proactive Investors UK


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