AGS-004: Phase IIb data
Top-line data from a double-blind, North American Phase IIb trial in 54 patients with chronic HIV-1 infection showed that AGS-004 missed the primary endpoint of a ³1.1 log reduction in viral load after the 12-week ART interruption period vs. placebo. AGS-004 also showed no significant differences vs. placebo on the secondary endpoints of a lower pre-ART viral load compared to viral load after the 12-week ART interruption period, changes in CD4+ T cells and viral kinetics. Of patients who received AGS-004 and completed the 12-week ART interruption period, about 70% had positive antiviral memory T cell responses prior to ART interruption vs. 0% for placebo. Additionally, patients in the AGS-004 arm who had antiviral memory T cell responses had significantly fewer CD4+ T cells with integrated HIV DNA vs. immune non-responders. Argos said the data suggest that AGS-004-induced antiviral memory T cell responses “may contribute to lower persistent viral reservoirs.” ...