[이코노믹리뷰=황진중 기자] Bukwang Pharmaceutical (003000) announced on the 5th that it has received approval from the US Food and Drug Administration (FDA) for the Phase 2 clinical trial plan (IND) of Levovir (ingredient name clevudine) for COVID-19 treatment.
This clinical trial is conducted with placebo-controlled, randomized, and double-blinded outpatients. It is composed of a design that evaluates the efficacy and safety of how much Corona 19 virus in the body can be reduced by administering levovir and placebo to 40 patients with Corona 19, excluding severe cases.
Bukwang Pharm completed the registration of patients in phase 2, which was conducted for moderate patients in Korea in relation to Levovir. After the administration is complete, the results are being analyzed, and from January this year, additional clinical trials are underway to confirm the reduction of live infectious viruses through the coronavirus cell culture test of Levovir.
Levovir has a domestic patent for Corona 19 registered on August 11 last year. An international patent (PCT), which has priority in more than 150 countries including the United States, was also filed on August 5.
An official at Bukwang Pharm said, “We have accumulated abundant clinical experience through clinical trials on antiviral drugs, central nervous system drugs, and diabetes drugs that have already been conducted globally.” We expect to be able to prove our competitiveness as an antiviral agent internationally by securing data.”