【Youth Daily】 Bukwang Pharm announced on the 5th that it has received approval from the US Food and Drug Administration (FDA) for a phase 2 clinical trial plan (IND) of’Levovir’ (Clevudine), which is being developed as a treatment for COVID-19.
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 Revovir can reduce the Corona 19 virus in the body of corona patients compared to placebo by administering Levovir and placebo to 40 patients with COVID-19 excluding severe cases.
Levovir has already completed patient registration in a phase 2 clinical trial conducted in Korea with moderate patients, and is ahead of the analysis of the results after the administration is complete. Since January of this year, additional clinical trials are underway that can confirm the reduction of the infectious virus through Levovir’s coronavirus cell culture test.
Levovir has a domestic patent for Corona 19 registered on August 11 last year, and an international patent (PCT) that has priority in more than 150 countries, including the United States, has also been 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 treatments that have already been conducted globally.” We expect to be able to secure data and prove our competitiveness as an antiviral agent internationally.”
【Youth Daily = Reporter Ahn Sang-jun】