GSK Hepatitis B Drug Cures One Fifth of Patients in Late-Stage Trials

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

British pharmaceutical company GSK announced that its hepatitis B drug candidate bepirovirsen delivered a functional cure for nearly one fifth of patients in two late-stage clinical trials, which the company sees as a breakthrough in the treatment of the disease.

Trial Results and Efficacy Rates

On Thursday, GSK released full results from two phase 3 studies showing that 19% of chronic hepatitis B patients achieved a functional cure response rate after six months of weekly bepirovirsen injections. In a smaller group of patients with lower viral activity, the cure rate reached 26%.

Major Improvement Over Current Therapies

The company stated that bepirovirsen has the potential to redefine treatment for a disease where current standard care typically requires lifelong therapy and achieves functional cure rates of less than 1%. Analysts at Jefferies had noted that a cure rate of 15% to 20% would represent a major improvement given the efficacy of current standard therapies.

Regulatory Process and Future Plans

GSK has filed for regulatory approval for bepirovirsen in the U.S., Japan, China, and Europe. The U.S. Food and Drug Administration has set an October deadline for its decision. The company expects bepirovirsen to become the backbone of other therapies.