Celltrion Begins Preventive Clinical Trial of COVID-19 Antibody Treatment

Conducted on 1,000 Close Contacts and Asymptomatic Confirmed Cases

[Asia Economy Reporter Seo So-jung] Celltrion announced on the 12th that it received approval from the Ministry of Food and Drug Safety on the 8th for the clinical trial plan (IND) of the phase 3.3 prevention clinical trial of the novel coronavirus infection (COVID-19) antibody treatment ‘CT-P59’ and will proceed with phase 3 clinical trials.

This prevention clinical trial will be conducted on close contacts and asymptomatic confirmed cases, with approximately 1,000 participants primarily in South Korea. Celltrion plans to verify the infection prevention effect and early virus elimination effect in the prevention clinical trial.

Antibody treatments like CT-P59 form antibodies in the body immediately upon administration, so when administered to high-risk groups for COVID-19 such as healthcare workers in close contact with patients and elderly people with weakened immunity, infection prevention effects can be expected.

Celltrion has proven the safety of CT-P59 in a domestic phase 1 clinical trial involving healthy subjects, and recently received approval from the Ministry of Food and Drug Safety to conduct phase 2 and 3 clinical trials targeting mild to moderate patients. Celltrion plans to accelerate the ongoing phase 2 clinical trial on patients as well as the newly approved prevention clinical trial to speed up the early commercialization of the COVID-19 treatment.

In close prior consultation with the Ministry of Food and Drug Safety, Celltrion is also considering applying for conditional approval if the clinical results meet the standards. Since September, Celltrion has started producing process validation batches at the company’s mass production facility and has been adjusting existing product inventory and production plans in preparation for large-scale supply of the treatment domestically and internationally.

Lee Sang-jun, Senior Vice President and Head of Clinical Development at Celltrion, said, “Following the recent approval of phase 2 and 3 clinical trials for mild and moderate patients, we have also received approval from the Ministry of Food and Drug Safety for the prevention clinical trial, officially advancing the clinical development of the COVID-19 antibody treatment.” He added, “From the prevention clinical stage, we will demonstrate the importance of early diagnosis and early treatment to contribute to preventing the spread of COVID-19 and ending the crisis.”

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