Celltrion has begun recruiting mild Covid-19 patients for the Phase 1 clinical trial of its antibody therapy, CT-P59, after obtaining approval for an investigational new drug program from the Ministry of Food and Drug Safety.
The clinical trial assesses the safety, tolerability, and neutralizing ability of CT-P59 in mild Covid-19 patients, the company said in a news release Wednesday.
|Celltrion will conduct a phase 1 clinical trial of its antibody therapy, CT-P59, on mild Covid-19 patients. (Celltrion)|
Many medical institutions, including Incheon Medical Center, Gacheon University Gil Medical Center, and Inha University Hospital, will work with Celltrion to conduct the research.
Celltrion also won approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for clinical trials of Covid-19 in late July. It is conducting a global phase 1 study on patients with mild symptoms.
The company aims to complete the recently approved domestic phase 1 trial at an early date, which has the same clinical structure as the ongoing study in the U.K.
Separately, Celltrion has been conducting a phase 1 trial of CT-P59 on healthy people at Chungnam National University Hospital (CNUH) to conclude study results within the third quarter of 2020.
With the studies in progress, the company plans to run phase 2, 3 clinical studies on mild Covid-19 patients and a phase 3 trials for preventive purpose and patents with moderate symptoms, to secure interim results by the end of this year.
In the case of preventive clinical trials, those who had close contact with confirmed patients and asymptomatic patients would be recruited to check how well CT-P59 kills the virus in the early stages of infection and its preventive effect.
As soon as Celltrion gains permission for using CT-P59, it will establish a mass supply system by increasing its commercial production by 10 times or more from September.
“We have successfully administered CT-P59 on healthy people in the phase 1 trial at CNUH, and is putting a finishing touch to it, Celltrion Senior Vice President Lee Sang-joon said. The company also has just begun global trials in earnest by entering into phase 1 study on mild patients, he added.
“Celltrion will complete the administration of the drug at an early date by speeding up global phase 1 trial,” Lee said. “Our researchers are also going all out to integrate various sets of global phase 2, 3 trials into two phase 3 trials.”
<© Korea Biomedical Review, All rights reserved.>