In addition, Gilead has several ongoing research programs with the goal of achieving functional cure for HBV-infected patients. Preclinical data with some of Gilead’s novel investigational compounds are being presented at the Congress.
GS-5801 is an oral liver-targeted prodrug of a small molecule inhibitor of KDM5, a histone lysine demethylase. Results from in vitro preclinical studies (#SAT-160) demonstrated activity of GS-5801 in HBV-infected primary human hepatocytes with significant declines in viral proteins and HBV RNA. In addition, in vivo data (#THU-171) demonstrated the pharmacodynamic response of GS-5801 within the liver, in animal models. GS-5801 is currently being evaluated in Phase 1 trials in healthy subjects and in patients with chronic HBV infection.
GS-9688, an oral selective toll-like receptor 8 (TLR8) agonist, demonstrated in vitro and in vivo pharmacodynamic effects consistent with selective TLR8 activation, including the production of antiviral cytokines (#SAT-168). Further, in an efficacy animal model of chronic HBV infection, GS-9688 treatment demonstrated a sustained antiviral response in chronically infected woodchucks (#SAT-165). GS-9688 is currently being evaluated in Phase 1 trials in healthy subjects and in patients with chronic HBV infection.
Further information about the clinical studies described above can be found at http://anzctr.org.au/.
GS-5801 and GS-9688 are investigational products and have not been determined to be safe or efficacious.