Top-line results announced for Phase 2 study of GS-4774 in patients with chronic hepatitis B

GlobeImmune has announced top line results from the GS-4774 Phase 2 study in patients with chronic hepatitis B (HBV) on long term viral suppression with an oral antiviral treatment.

GS-4774, exclusively licensed to Gilead Sciences, is a therapeutic vaccine engineered to activate an HBV-specific T cell immune response to eliminate, or clear virus from, cells containing HBV.

In this study, patients 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, but at 48 weeks had a mean -0.17 log₁₀ reduction of HBsAg compared with a -0.04 log₁₀ reduction in the OAV alone group (p=not significant). Three patients receiving the highest dose of GS-4774 had HBsAg reductions between -0.94 and -3.89 log₁₀ at 48 weeks. There was no difference in HBsAg reductions between the two lowest dose groups versus the control arm at 48 weeks. Further characterisation of the T cell response to GS-4774 and association with HBsAg changes are ongoing.

GlobeImmune to work with partner Gilead to identify next steps for GS-4774

GS-4774 was found to be generally safe and well tolerated, with injection site reactions identified as the primary adverse event. Data from this trial are expected to be submitted for future presentation and publication.

“We believe that this first Phase 2 trial of GS-4774 in virally-suppressed patients suggests initial biologic activity at the highest dose tested,” said Timothy C. Rodell, M.D., FCCP, President and CEO of GlobeImmune, Inc. “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.”