[Photo provided by Celltrion]
South Korea’s Celltrion said on Thursday that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a phase 1 trial of its CT-P59, an investigational antibody treatment against COVID-19. Patient enrollment will soon begin across the country.
The phase 1 trial is designed to evaluate the med’s safety and efficacy in the neutralization of coronavirus in patients with mild symptoms.
Celltrion shares fell 0.5 percent to close Thursday at 300,000 won ($251) in Seoul.
Based on any positive results from this trial, Celltrion plans to take the treatment into phase 2 and 3 trials in patients with mild to moderate symptoms globally, with a goal of presenting interim data by the end of this year. The company will also carry out a separate clinical trial to evaluate the drug as a prophylactic within this year in subjects who have been in close contact with confirmed COVID-19 patients. It is in talks with other European countries to conduct this study.
In Korea, the CT-P59 trial protocol was approved by the Ministry of Food and Drug Safety on July 17 and a phase 1 study is underway in 32 healthy volunteers at Chungnam National University Hospital. Results are expected to come out by the end of September.
Celltrion said it will begin commercial production of CT-P59 from September in advance to ensure immediate supply to the global market upon marketing approval next year.
By Minu Kim
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]