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 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 with mild-to-moderate symptoms of the novel coronavirus to evaluate the efficacy and safety of CT-P59, also known as Regdanvimab.
Celltrion said CT-P59 decreased the rate of COVID-19 patients developing severe cases, which require hospital care, by 54 percent.
Also, it cut recovery time by more than three days, the company said, adding there has been no serious adverse drug reaction among the patients who took part in the clinical trials.
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.
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.