FB2001 (Bofutrelvir) is a Coronavirus Mpro inhibitor, which has exhibited potent anti-SARS-CoV-2 activity in vitro and in vivo.
Phase 1 results show FB2001 to be generally safe and well tolerated. Single-agent antiviral concentrations have been reached in the blood plasma and lung tissues without the need for pharmacokinetic enhancer, thus potentially minimizing the risk of drug interactions
It significantly reduces coronavirus viral load in the lungs and brain of a murine model, the latter which may have clinical implications for the sequelae of the central nervous system of COVID-19. FB2001 is the first anti-COVID-19 drug to report antiviral activity in the brain.
The BRIGHT (Bofutrelvir in Global Hospitalized Patients) study, a Phase 2/3 trial that explores the utility of FB2001 in reducing the time to recovery in patients hospitalized due to COVID-19 is currently on-going.