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GBIM<>GlobeImmune therapeutic vaccine candidate for hepatitis B flunks Phase 2 study

A Phase 2 clinical trial evaluating GlobeImmune's (NASDAQ:GBIM) GS-4774, a therapeutic vaccine candidate for hepatitis B infection, failed to achieve its primary efficacy endpoint of demonstrating a reduction in hepatitis B surface antigen (HBsAg) at week 24 in patients treated with the highest dose of GS-4774 plus ongoing antiviral therapy (OAV) compared to OAV alone. There was a slight increase in viral knockdown in the test group at week 48 but the difference was not statistically significant.
The 178-subject, randomized, open-label study was designed to assess three different doses of GS-4774 in combination with ongoing oral antiviral therapy in patients with chronic HBV infection whose disease was under control with OAV. The analysis of the data and characterization of the T cell response to GS-4774 and its relationship to HbsAg changes are ongoing.
GS-4774 is exclusively licensed to Gilead Sciences (NASDAQ:GILD).
The data will be presented at a future medical conference and will be submitted for publication.