Celltrion said that the U.K.’s Medicines and Healthcare products Regulatory Agency has given it the go-ahead to conduct phase 1 clinical trials of CT-P59, a Covid-19 treatment candidate.
|The U.K. Medicines and Healthcare products Regulatory Agency has approved Celltrion’s phase 1 clinical trial of its Covid-19 treatment. (Celltrion)|
This phase 1 clinical trial in the U.K. will identify early indicators of drug efficacy, such as the neutralizing and medicinal efficacy of CT-P59 in patients with mild Covid-19.
Celltrion also plans to conduct phase 2 and 3 clinical trials of patients with mild or moderate symptoms after the phase 1 study in the U.K. The company also plans to secure intermediate results for all clinical trials by the end of this year, and conduct preventive clinical trials for close contacts by the first quarter of next year.
To this end, the company is already preparing for phase 2 and 3 clinical trials in close consultation with some European countries.
The Ministry of Food and Drug Safety approved the clinical trial plan of CT-P59 on July 17. The company is currently conducting the trial on 32 healthy subjects at Chungnam National University Hospital, with the aim of securing results within the third quarter of this year.
“Celltrion plans to supply existing products to the global market without disruption by comprehensively considering existing product inventory and production plans,” the company said. “The company has begun adjusting its capacity plan for next year to include the production of CT-P59.”
Celltrion Vice President Lee Sang-jun said, “With the active support from the Ministry of Food and Drug Safety and Chungnam National University, phase 1 clinical trials in Korea are proceeding smoothly, and the pace of CT-P59 development is also gaining speed.”
The company will do its best to smoothly finish the phase 1 trials for mild patients in the U.K., and thoroughly prepare to complete the phase 2 and 3 global clinical trials to contribute to ending the currently Covid-19 crisis, Lee added.