SEOUL, Jan. 6 (Korea Bizwire) — South Korean biotech company GC Pharma said Wednesday it has completed phase two clinical trials of its plasma therapy treatment for the novel coronavirus.
The plasma therapy, known as GC5131A, is a type of hyperimmune globulin drug that uses blood plasma taken from people who have fully recovered from COVID-19.
GC Pharma wrapped up the phase two clinical study on Dec. 31 and plans to file for a conditional approval to the Korean Ministry of Food and Drug Safety during the first quarter of this year.
GC Pharma said it has already completed the production of its third batch, meaning the treatment candidate is expected to be available at medical institutions immediately.
The second-phase clinical trial of the investigative drug was conducted at 15 local trial sites, including major general hospital Samsung Medical Center, on COVID-19 patients with severe symptoms.
Experimental drugs under clinical trial are sometimes granted approval for emergency usage from the Ministry of Food and Drug Safety in cases where diseases are life-threatening and there is no other treatment option.
People who have recovered from COVID-19 develop natural defenses against the disease in their blood, in which antibodies are found in the part of the blood called plasma, the company said.
A key to developing potential hyperimmune globulin treatment is the collection of convalescent plasma.