SEOUL, July 17 (Korea Bizwire) — South Korea approved phase one clinical trials for Celltrion Inc.’s coronavirus antibody treatment substance, the country’s drug safety agency said Friday.
The move to test CT-P59 marks the first time that a locally made genetic recombination antibody treatment material has been given the green light to be used on people, the Ministry of Food and Drug Safety said.
Past approvals given by the ministry were so-called repositioning research, to see if drugs already in use for other ailments are effective in combating COVID-19.
“Celltrion will be allowed to use the CT-P59 on 32 healthy volunteers to see if it is safe, and has no side effects,” the ministry said. The tests will be carried out at Chungnam National University Hospital.
If the initial tests that should be completed by the third quarter are successful, the pharmaceutical company will conduct second and third phase clinical trials afterward, and if the data collected are all positive, production can begin,
The ministry, which is pushing hard to have a locally made treatment drug, said if all goes well, Celltrion could start mass producing the drug in the first half of 2021. The initial output could be for 5 million people.
Besides local testing, Celltrion is in the process of getting approval from Britain to conduct clinical trials for its material in that country.
Celltrion, meanwhile, said that CT-P59 has shown it can be effective in treating a mutated form of the coronavirus that is spreading in the country.
The start of trials, meanwhile, brings to 13 the number of tests that are being conducted on COVID-19 treatment and vaccine materials in the country.
Of these, 11 are treatment drugs and two are vaccines, with most being materials brought in from abroad like remdesivir, a drug developed by U.S.-based drug giant Gilead to treat Ebola.