By Adria Calatayud
GSK said a drug candidate for hepatitis B helped nearly a fifth of patients who enrolled in two late-stage clinical trials achieve a functional cure.
The U.K. drugmaker on Thursday released results from two phase 3 trials for the drug, bepirovirsen, which showed 19% of hepatitis B patients achieved a functional cure response rate in the overall study population after a six-month treatment. The drug delivered a functional cure rate of 26% in a smaller group of patients with lower viral activity, the company said.
GSK is looking to speed up the launch of the medicines it has in the pipeline, as part of GSK Chief Executive Luke Miels' plan to offset upcoming patent expirations. Miels singled out bepirovirsen in a recent earnings call, saying it would materially change the treatment of hepatitis B.
Hepatitis B is a serious liver infection, which can lead to liver damage, cancer and death. GSK said the drug has potential to redefine the treatment of a disease for which the current standard of care typically requires lifelong therapy and achieves functional cure rates of less than 1%.
The company filed for regulatory approval for bepirovirsen in the U.S., Japan, China and Europe after it reported initial data from the trials early this year. The U.S. Food and Drug Administration has set an October deadline for its decision, said Melanie Paff, vice president and medicines development leader for hepatitis B at GSK.
Bepirovirsen is a so-called antisense oligonucleotide injection, designed to stop the hepatitis B virus from replicating, reduce the level of an antigen that is made by the virus in the blood, and reinvigorate the immune system, the company said. GSK licensed the drug from Ionis Pharmaceuticals.
Write to Adria Calatayud at adria.calatayud@wsj.com
(END) Dow Jones Newswires
May 28, 2026 04:39 ET (08:39 GMT)
Copyright (c) 2026 Dow Jones & Company, Inc.