기업
Celltrion, received approval for processing the phase 2/3 clinical trial of COVID-19 Antibody, 'CT-P59'
바이오스펙테이터 Yoonseok Suh 기자
Clinical approval for mild to moderate COVID-19 patients. Planning on the efficacy and safety evaluation.
Celltrion has been approved by the MFDS for phase 2/3 clinical trials of COVID-19 antibody.
Celltrion announced on the 17th that the MFDS has approved the domestic clinical trial phase 2/3 of 'CT-P59', a COVID-19 antibody treatment. Celltrion is entering clinical trials for mild to moderate COVID-19 patients.
According to the announcement, Celltrion is conducting phase 2/3 clinical trials of CT-P59 for Korean and global COVID-19 patients. In Korea, it is expected to end clinical trials later this year in cooperation with 10 medical institutions including the National Medical Center.
Currently, Celltrion has submitted clinical trial plans (IND) to six countries including the United States and Spain, and plans to conduct global clinical trials on more than 1,000 patients in up to 12 countries. Celltrion expects to be able to confirm the interim results of phase 2/3 clinical by the end of this year.
In addition to phase 2/3 of the clinical trial, Celltrion plans to conduct preventive clinical trials for close contacts and asymptomatic patients by the end of the year. The goal is to confirm the effect of preventing infection and killing the virus in the early stage of infection.
"With the approval of phase 2/3 of the clinical trial, the clinical trial for patients with mild and moderate COVID-19 of CT-P59 has started in earnest. In addition to the ongoing phase 1 clinical trial, phase 2/3 of the clinical trial will proceed without disruption, and we will develop a treatment as soon as possible”, said Sang-jun Lee, senior vice president of Celltrion and Head of Clinical Development division.
Meanwhile, Celltrion is also considering applying for conditional approval if the results of global phase 2 clinical trials meet the standards of the MFDS. Celltrion already began production of CT-P59 in process validation batches from this month, and plans to adjust existing product inventory and production plans in preparation for mass supply of COVID-19 treatments in domestic and overseas markets in the future.
