GlaxoSmithKline (GSK) has started phase 3 clinical trials for its hepatitis B treatment candidate, ‘bepirovirsen’.
According to local media such as Biopharma Live in the U.S. on the 6th, GSK recently announced that it would start two phase 3 clinical trials for bepirovirsen in its fourth quarter earnings report. GSK also introduced that among drug candidates currently under development, bepirovirsen is a priority candidate.
Bepirovirsen is an antisense oligonucleotide treatment. In the last phase 2 clinical trial, bepirovirsen was used to detect hepatitis B surface antigen (HBsAg) or hepatitis B virus (HBV) DNA in patients who are being treated with nucleoside or nucleoside analog (NA) or who are not being treated with NA. has reduced
GSK plans to evaluate the efficacy compared to placebo in patients in this phase 3 clinical trial (B-Well 1 or B-Well 2). Both studies are expected to produce results by October 2025.
About 300 million people, or regarding 4% of the world’s population, are known to have hepatitis B. Hundreds of thousands of people die from this disease every year.
Currently, Gilead’s ‘Vilead’ (component tenofovir dasoproxil) and Bristol-Myers Squibb’s ‘Baraclude’ (component entecavir) can control hepatitis B infection to some extent with a similar role, but completely cure it. I can’t. Bepirovirsen is attracting attention because it is expected to be able to cure hepatitis B.
The drug targets the hepatitis B virus RNA (ribonucleic acid) and reduces the binding of the virus to cells in the body. In addition to bepirovirsen, GSK is also developing a phase 2 clinical trial of oligonucleotide therapy for the treatment of non-alcoholic steatohepatitis (NASH). Last December, it also agreed to work with Wave Life Sciences to develop further drug candidates of this type.
In the overseas medical journal ‘New England Journal of Medicine (NEJM)’, which published the results of the phase 2 clinical trial last November, Jay Hoppangle, the head of liver disease research at the US National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), spoke regarding bepirovirsen. “A new era of hepatitis B control may be coming,” he said.
GSK is currently conducting phase 2 clinical trials combining bepirovirsen with other therapies, and the results of the study are expected to come out in 2023.
jjsung@news1.kr
