Bukwang Pharmaceutical Antiviral Drug Approved for COVID-19 Treatment Clinical Trial

Bukwang Pharmaceutical's hepatitis B treatment 'Rebovir'

[Asia Economy Reporter Choi Dae-yeol] The Ministry of Food and Drug Safety approved on the 14th a clinical trial plan to evaluate whether Levovir (active ingredient: clevudine), an antiviral drug developed by Bukwang Pharmaceutical, is effective in treating the novel coronavirus infection (COVID-19). This Phase 2 clinical trial is the fastest among domestically developed substances.

According to the clinical trial plan approved on the same day, the company will administer Levovir capsules and hydroxychloroquine, originally developed as a malaria treatment, to patients with moderate COVID-19 to assess safety and efficacy. Previously, the company confirmed that this drug showed results similar to the HIV treatment drug Kaletra in in vitro tests, and based on this, they also filed a patent.

Clevudine is an antiviral drug developed by Bukwang Pharmaceutical and was the fourth in the world and the first in Asia to be marketed as a treatment for hepatitis B virus. The company explained that clevudine is a nucleoside analog that inhibits the replication of viral genetic material.

There is currently no treatment specifically targeting COVID-19. Clinical trials are underway domestically and internationally to test whether drugs such as remdesivir, Kaletra, and chloroquine?originally developed as Ebola treatments?are effective against COVID-19. This is drug repositioning, which examines new indications for previously developed drugs. Since it does not require going through early stages such as candidate selection and toxicity evaluation, the development period can be shortened. As COVID-19 spreads worldwide, such clinical trials are being conducted successively in various countries. This is the first clinical approval among treatments developed domestically.

At the time of the patent application, the company stated, "The mechanism by which clevudine inhibits coronavirus infection is not yet clear," but added, "Kaletra is a drug used to treat AIDS, and remdesivir, which is being developed as a COVID-19 treatment, was originally developed for Ebola virus and is a nucleoside analog that inhibits viral genetic material replication."

This content was produced with the assistance of AI translation services.