GS-4774 for HBV fails to meet primary endpoint in phase 2 trial

Results from a phase 2 trial of GS-4774 for the treatment of chronic hepatitis B virus infection showed that patients treated with the highest dose of the drug, in addition to ongoing oral antiviral therapy, failed to meet the study’s primary endpoint through no reduction in hepatitis B surface antigen after 24 weeks of therapy, according to a press release from the manufacturer.

The goal of the trial is to investigate GS-4774 in combination with ongoing oral antiviral treatment in patients with chronic HBV infection whose infection is currently under control with an oral antiviral therapy, according to the release. The trial enrolled 178 patients who will be randomly assigned three different doses of GS-4774 in combination with oral antiviral therapy and compared with patients receiving antiviral treatment alone.

Although the primary endpoint was not met in this part of the trial, treatment was found to reduce hepatitis B surface antigen (HBsAg) at 48 weeks in patients receiving GS-4774 and oral antiviral therapy compared with patients receiving oral antiviral therapy alone, but was insignificant (mean –0.17 log₁₀ reduction vs. mean –0.04 log₁₀ reduction). Three patients receiving the highest dose of GS-4774 had HBsAg reductions between –0.94 and –3.89 log₁₀ at 48 weeks, according to the release, but there was no difference in HBsAg reductions between the two lowest dose groups compared with the control arm at 48 weeks.

“We believe that this first phase 2 trial of GS-4774 in virally-suppressed patients suggests initial biologic activity at the highest dose tested,” Timothy C. Rodell, MD, FCCP, president and chief executive officer of GlobeImmune, said in the release. “We look forward to collaborating with our partner Gilead Sciences to identify potential next steps for GS-4774 in this patient population as well as to seeing the results from the second ongoing phase 2 trial of GS-4774 in HBV treatment-naive patients.” – by Melinda Stevens

Disclosure: Rodell is employed by GlobeImmune.