GSK Hepatitis B Drug Candidate Cures Patients in Late-Stage Trials

GSK's Hepatitis B Drug Candidate Bepirovirsen Achieves Functional Cure in 19% of Patients in Late-Stage Trials

British pharmaceutical company GSK announced that its hepatitis B drug candidate bepirovirsen achieved a functional cure in nearly one-fifth of patients enrolled in two phase 3 clinical trials. The company reported a 19% functional cure rate in the overall study population after six months of treatment, and a 26% rate in a smaller group of patients with lower viral activity.

A Significant Step Forward Compared to Current Treatment

Hepatitis B is a serious liver infection that can lead to liver damage, cancer, and death. GSK emphasized that bepirovirsen represents a major advancement over the current standard of care, which typically requires lifelong therapy and achieves functional cure rates of less than 1%.

Regulatory Submissions and Future Plans

Following initial data from the trials earlier this year, GSK has filed for regulatory approval in the U.S., Japan, China, and Europe. The U.S. Food and Drug Administration (FDA) is expected to make a decision by October. The drug is an antisense oligonucleotide injection designed to stop the hepatitis B virus from replicating, reduce antigen levels, and reinvigorate the immune system.