FDA Fast Track for GSK's Bepirovirsen in Chronic Hepatitis

GSK plc announced that the US Food and Drug Administration (FDA) Fast Track designation for bepirovirsen, an antisense oligonucleotide (ASO) probe for the treatment of chronic hepatitis B (CHB). Fast Track designation allows rapid development and evaluation of drugs to treat serious diseases and address unmet medical needs.

The designation was requested based on Bepirovirsen's ability to address the unmet medical need for CHB, which is a serious life-threatening disease. Data from the Phase IIb B-Clear and B-Sure clinical trials evaluating the efficacy, safety and duration of response of bepiroversen in patients with CHB were submitted to support the application. Yes, there is a three-part confirmation program that is underway.

CHB affects approximately 300 million people worldwide, and current treatment options have a functional recovery rate of less than 2-8%, with no clinical benefit. Useful therapy occurs when the levels of the hepatitis B virus and viral proteins in the blood are undetectable and can be controlled by the immune system without medication. Oral medications currently available only suppress the virus and do not directly reduce hepatitis B antigen (HBsAg), which is critical for effective therapy.

Bepirovirsen is the only agent in Phase 3 development that can achieve clinically meaningful clinical responses when combined with a nucleoside/nucleotide analog (NA). The positive results of the B-Clear and B-Sure clinical trials demonstrate this. B-Clear found that patients with low levels of hepatitis B surface antigen benefited from treatment with bepirovirsen. Bepirovirsen is also being studied as a possible backup treatment in future series to achieve functional therapy in a larger group of CHB patients.