Bukwang Pharmaceutical Co., Ltd. announced that they concluded patient recruitment for the phase 2 clinical trial of covid-19 treatment with Levovir. The number of patients is 104(the initial goal was 80 patients) and Bukwang is going to file the data right after the final patient’s clinical progression and submit it to the Ministry of Food and Drug Safety for the next steps.
Clevudine, the active ingredient of Levovir®, is an antiviral drug fully developed by Bukwang. It has been under development for treating COVID-19(CLV-203) in the mild to moderate stage to find out if it would reduce the infectivity of the virus through cell culture.
Prior to this study(CLV-203), the CLV-201 which was already conducted before, showed that there was a more clear tendency of virus reduction in patients who were treated with Levovir when compared to patients in the placebo group. Subgroup analysis was conducted with 22 hypertension patients, and patients who had N gene showed statistically significant virus reduction in the Levovir group when compared to the placebo group. (p<0.05)
Also, the patent application of Levovir against SARS-Cov-2 virus isolated from a sample of a Korean coronavirus infectious disease-19 (COVID-19) patient was granted on 11st August. PCT application has also been filed on 5th August.
The registered patent was filed with Levovir’s experimental data in human lung cells (CALU-3 cells) where Remdesivir was used as positive control, and in non-human primate kidney cells (VERO cells) where lopinavir-ritonavir, and chloroquine were also tested.
Bukwang announced that they could secure competitiveness if they can improve the reduction of the virus infectivity through this study(CLV-203) with reliable data.