SEOUL, Sept. 21 (Korea Bizwire) — South Korea’s biotech company GC Pharma will soon begin advanced clinical trials of its plasma therapy treatment for the novel coronavirus both locally and globally, company officials said Monday.
The plasma therapy, known as GC5131, is a type of hyperimmune globulin drug that uses blood plasma taken from people who have fully recovered from COVID-19 infections. It is considered one of the earliest treatment options.
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.
Key to developing potential hyperimmune globulin treatment is the collection of convalescent plasma.
Last month, the Ministry of Food and Drug Safety gave the green light to administer the investigative therapy to COVID-19 patients to evaluate its safety and efficacy.
The ministry said it has skipped the phase one clinical trial after evaluating the widely recognized safety profile of a plasma medication.
A second-phase clinical trial of the investigative drug will be conducted at six local trial sites, including major general hospital Samsung Medical Center, later this week, according to them.
CoVIg-19 Plasma Alliance, a partnership of the world’s leading plasma companies including GC Pharma, will also conduct a phase three clinical trial of the plasma therapy later this month.
The global plasma collaboration was established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19. The alliance includes global blood product manufacturers such as BPL, CSL and Takeda.
The global study has skipped both phase one and two clinical trials, GC Pharma said.
The National Institute of Allergy and Infectious Diseases under the National Institute of Health will lead the global study in adult patients with COVID-19.