Celltrion receives permission for Phase 1 trials of CT-P59

Celltrion received approval for Phase 1 clinical trials for a Covid-19 treatment candidate, the Ministry of Food and Drug Safety announced Friday.

The CT-P59 antibody candidate will be tested on 32 healthy people to verify that it is safe. Antibodies can neutralize the effects of a virus. The Phase 1 trials are scheduled to be completed by the third quarter, Celltrion said. To speed up the process, the company manufactured test dosages before the approval was received.

The plan is to carry out tests not only in Korea. Celltrion said it is in the final stage of discussions with health authorities in Britain to carry out Phase 1 clinical trials of CT-P59.

After Phase 1, Phase 2 and Phase 3 trials will be conducted to verify safety and efficacy before the substance receives a final nod.

The goal is to start production of enough of the treatment for 5 million patients during the first half of 2021.

As of Friday, the Drug Ministry approved clinical trials for 11 Covid-19 treatment candidates and two vaccines. Most of those treatment candidates are drugs that were originally commercialized to combat diseases other than Covid-19 but were found to have an effect on Covid-19.

Celltrion’s CT-P59 is now the only treatment candidate on the list that’s an entirely new substance and also the only antibody treatment. The company first discovered it in February after screening antibodies from the blood of a Covid-19 patient. Celltrion is one of the two Korean companies that partnered with the local government to develop new drugs specifically targeted to treat the pandemic.

The other local pharmaceutical company, GS Pharma, recently secured enough donors to conduct Phase 2 clinical trials of its plasma treatment and is preparing to start tests this month.

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]