Chronic Hepatitis B Treatment Receives U.S. FDA Fast Track Designation

GSK plc 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). 

GSK said on February 12, 2024, 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).

The FDA 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 the response of bepirovirsen in people with CHB, were submitted to support the application. A confirmatory phase III program, B-Well, is ongoing.

CHB affects nearly 300 million people worldwide, and current treatment options offer a less than 2-8% functional cure rate, which is not clinically meaningful. 

Currently, available oral antiviral therapies only suppress the virus and do not directly lower hepatitis B surface antigen, which is essential for a functional cure.

Bepirovirsen is a triple-action investigational antisense oligonucleotide. It is also being investigated as a potential backbone therapy in future sequential regimens to pursue functional cures in a broader population of patients with CHB.

FDA 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.

Bepirovirsen (previously known as 'ISIS 505358 or IONIS-HBVRX') was discovered and is jointly developed with Ionis Pharmaceuticals.

GSK is a global biopharma company that aims to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. GSK's unedited press release is available at this link.