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.