GSK published positive end of study results from a phase 2b trial evaluating its investigational antisense oligonucleotide for the treatment of chronic hepatitis B and, despite a significant drop in efficacy from the interim analysis, plans to move the drug into phase 3 trials.
The results from the B-Clear trial showed that GSK's experimental treatment, bepirovirsen, resulted in 9% of patients on stable nucleoside/nucleotide analogues (NA) and 10% of patients not-on-NA achieving the primary study outcome — sustained clearance of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA.
The end of study results show a drop in efficacy from June's interim analysis, which found that 28% of patients receiving NA treatment and 29% of patients not on NA reached the study's primary outcome.
Chronic hepatitis B is a major global health threat that can progress to liver complications including cirrhosis and liver cancer. According to GSK, the final study results still offer hope that bepirovirsen might be a potential treatment, either as monotherapy or in combination with NAs, and that the drug could result in functional cure.
The drugmaker plans to start a phase 3 trial evaluating bepirovirsen in the first half of next year.
