Safety, pharmacokinetics, and pharmacodynamics of the oral TLR8 agonist selgantolimod in chronic hepatitis B.

Abstract

BACKGROUND & AIMS: In patients with chronic hepatitis B (CHB) infection, activation of toll-like receptor 8 (TLR8) may induce antiviral immunity and drive functional cure. Selgantolimod, a novel TLR8 agonist, was evaluated in CHB patients who were virally suppressed on oral antiviral treatment (OAV) or viremic not on OAV. APPROACH & RESULTS: In this Phase 1b study, patients were randomized 4:1 to receive either selgantolimod or placebo once-weekly. Virally suppressed patients received either 1.5 mg (for two weeks) or 3 mg (for two weeks or four weeks). Viremic patients received 3 mg for two weeks. The primary endpoint was safety as assessed by adverse events (AEs), laboratory abnormalities, ..