(ATTN: UPDATES with more info throughout; CORRECTS info in 3rd para)
By Kim Han-joo
SEOUL, Jan. 13 (Yonhap) -- South Korean pharmaceutical giant Celltrion Inc. said Wednesday that its COVID-19 treatment candidate reduces recovery time and the chance of a severe case developing.
It was making public clinical data on the second-phase global trial study of the CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The firm earlier submitted an application for conditional marketing authorization of the product to the Korean Ministry of Food and Drug Safety (KMFDS).
The company conducted the trial on 327 patients of the novel coronavirus to evaluate the efficacy and safety of CT-P59, also known as Regdanvimab. Nearly 60 percent of the participants were COVID-19 patients with severe symptoms, including pneumonia.
Celltrion said CT-P59 decreased the rate of COVID-19 patients developing severe cases, which require hospital care, by 54 percent.
Among COVID-19 patients aged 50 or older, the rate of developing into severe cases was cut by 68 percent, Celltrion said.
Also, the treatment cut recovery time by more than three days, the company said. Among either COVID-19 patients with severe symptoms or aged 50 or older, the treatment cut recovery time by more than five-to-six days, it added.
"The trial study proved that the treatment remarkably reduced the rate of patients developing into severe cases and at the same time reduced recovery time," Eom Joong-sik, a medical professor at Gachon University, said.
The professor also highlighted CT-P59's efficacy among elderly patients, as the mortality rate of COVID-19 virus is especially high among the age bracket.
Celltrion also said there has been no serious adverse drug reaction among the patients who took part in the clinical trials.
Celltrion said the treatment has shown higher efficacy compared to two COVID-19 treatment candidates developed by U.S. pharmaceutical firms -- Eli Lilly and Regeneron Pharmaceuticals.
The KMFDS is reviewing its safety and efficacy, a crucial procedure for the manufacturing and sales of South Korea's first homegrown COVID-19 treatment.
Celltrion said it plans to conduct a global phase three clinical trial, a pivotal part of the study, in more than 10 countries to obtain more comprehensive safety and efficacy results of CT-P59.
The company also plans to submit an application for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration and for Conditional Marketing Authorization to the European Medicines Agency (EMA) in the coming months.
The company is also working to increase its manufacturing capabilities to meet the current global and domestic demand for the treatment CT-P59, which is expected to reach the maximum of 2 million doses.
CT-P59 takes the form of an intravenous injection that is directly injected into the vein for 90 minutes.
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