US-based biopharmaceutical firm GlobeImmune has presented top line results from its GS-4774 Phase II trial in patients with chronic hepatitis B on long term viral suppression with an oral antiviral treatment.
Exclusively licenced to Gilead Sciences, GS-4774 is a therapeutic vaccine engineered to activate an HBV-specific T cell immune response to eliminate or clear virus from cells containing HBV.
According to the firm, the patients in the 0101 Phase II trial treated with the highest dose of GS-4774 plus ongoing oral antiviral therapy (OAV) did not show a reduction in hepatitis B surface antigen (HBsAg) at week 24, the primary endpoint of the study.
In the study, patients at 48 weeks had a mean -0.17 log10 reduction of HBsAg compared with a -0.04 log10 reduction in the OAV alone group.
GlobeImmune president and CEO Dr Timothy Rodell said: "We believe that this first Phase II trial of GS-4774 in virally-suppressed patients suggests initial biologic activity at the highest dose tested.
"We look forward to collaborating with our partner Gilead Sciences, Inc. 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-naïve patients."
The company has designed 0101 trial to investigate GS-4774 in combination with ongoing oral antiviral treatment in patients with chronic HBV infection whose disease is currently under control with an oral antiviral therapy.
The study was a multicentre and multinational trial, which enrolled 178 patients in a randomised, open-label design comparing three different doses of GS-4774, including 2YU, 10YU and 40YU (one YU equal to 10 million yeast cells), administered in combination with oral antiviral therapy versus antiviral treatment alone.