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.

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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."

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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.