Celltrion's COVID-19 antibody treatment CT-P59 will begin recruiting patients in Britain after receiving clinical trial approval (CTA) from the UK's Medicines and HealthCare Products Regulatory Agency (MHRA) on July 29 (local time).
British Phase I clinical trial will focus on identifying early indicators of drug efficacy, including the viral neutralization and drug efficacy of CT-P59 for patients with COVID-19 mild cases.
"We will conduct two clinical trials for minor and secondary patients after the first phase of clinical trials, and secure interim results for these clinical trials by the end of the year. We also plan to conduct preventive clinical trials for close contact patients by the end of the year and secure the results by the first quarter of next year," Celltrion said on July 30.
After receiving approval from the Ministry of Food and Drug Safety on July 17 for the CT-P59 clinical trial plan, the company is conducting the first phase of clinical trials for 32 subjects at Chungnam National University Hospital and plans to secure results within the third quarter.
When the development of CT-P59 is completed next year, the company will begin full-scale commercial production in September so that mass supply can be made immediately.
"With the active support of the Ministry of Food and Drug Safety and Chungnam National University, the first phase of clinical trials in Korea is proceeding smoothly," said Lee Sang-joon, senior vice president and head of clinical development headquarters at Celltrion. "We will do our best to complete the first phase of clinical trials in the UK for mild patients."
