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▲ Bukwang Pharmaceutical. |
[에너지경제신문 이나경 기자] Bukwang Pharmaceutical 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. The design will be conducted to evaluate the efficacy and safety of how much Levovir can reduce the Corona 19 virus in the body of corona patients compared to placebo by administering levovir and placebo to 40 patients with new coronavirus infections excluding severe cases.
Levovir has already completed patient registration for a phase 2 clinical trial conducted in Korea with moderate patients, and is ahead of the analysis of the results after completion of the medication. Starting in January of this year, additional clinical trials are underway to confirm the reduction of live infectious viruses through a coronavirus cell culture test of Levovir.
Revovir has a domestic patent for Corona 19 registered on August 11, 2020, and an international patent (PCT) that has priority in over 150 countries including the United States has also been filed in August last year.
Bukwang Pharm said, “We have accumulated abundant clinical experience through clinical trials on antiviral drugs, central nervous system drugs, and diabetes treatments that have already been conducted globally.” We expect to be able to prove our competitiveness as an antiviral agent internationally by securing data.”
Reporter Lee Na-kyung [email protected]