Bukwang Pharmaceutical Co., Ltd. (“Bukwang”) announced that they received US FDA approval for Levovir(active ingredient: Clevudine) , as COVID-19 treatment phase 2 clinical study IND.
This is a randomized, placebo controlled and doubleiblind study for the 40 outpatients except the severe stage. This study has been designed to find out if Levovir would reduce the infectivity of the virus against placebo.
Bukwang has already done 60 patients recruitment for the clinical trial of Levovir as a COVID-19 treatment in Korea. It was for the moderate COVID-19 patients and the result will be shown soon. Furthermore, another clinical trial with Levovir is ongoing since January to find out if it would reduce the infectivity of active viruses through cell culture.
Levovir® granted a Korean patent on August 11th and the PCT application for 150 countries has also been filed on 5th August.
Bukwang has accumulated plenty of experience in developing new drugs including antiviral agents, CNS drugs and the treatments for diabetes through the global clinical trials. Bukwang announced that they can have competitiveness of Levovir with the data which would show its efficacy in decreasing viruses through these clinical trials in Korea and the US.