The Ministry of Food and Drug Safety said Thursday that it has approved Celltrion’s phase 2 and 3 clinical trials of CT-P59, a Covid-19 antibody candidate.

CT-P59 is a genetically modified neutralizing antibody therapy. The treating principle is to prevent infection by attaching the antibody therapy to the area that binds to the human cells on the surface of the Covid-19 virus. The company has applied for clinical trials in five countries, including the United States and Romania.

According to the ministry, there are currently 19 treatments and vaccines undergoing clinical trials related to Covid-19 in Korea -- 17 treatments and two vaccines.

The most recent approval comes as follow-up clinical trials of phase 1 clinical trial approved by the ministry in July and August as the regulator determined that it was possible to go ahead with the next stage of clinical trials as the results of phase 1 clinical trial in healthy people confirmed the safety and tolerability of CT-P59.

The two trials will evaluate the efficacy and safety of CT-P59 in mild to moderate Covid-19 patients.

“We approved phases 2 and 3 trials at the same time to explore the appropriate dosage and treatment effect for treating Covid-19,” the ministry said. “The phase 2 clinical trial will involve 300 patients to confirm efficacy and safety based on the confirmed dose.”

Based on the confirmed dose, a phase 3 clinical trial will follow on 720 subjects to verify its efficacy and safety, the ministry added.

“Given the high public interest in the development of Covid-19 therapeutics and vaccines, the government will quickly deliver information on the current status of clinical trials of the developed products,” the ministry said. “We will do our best to support the necessary matters to develop safe and effective Covid-19 treatments and vaccines and provide treatments for the public.”