GC Green Cross COVID-19 Plasma Therapy Phase 2 Clinical Trial Approved

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety announced on the 20th that it has approved the Phase 2 clinical trial plan (IND) for GC Green Cross's novel coronavirus disease (COVID-19) plasma treatment drug 'GC5131'.

Aside from drug repurposing studies that verify the COVID-19 treatment effects of already approved drugs, this is the first time that a developing COVID-19 treatment has received approval for a Phase 2 clinical trial.

GC5131 is a pharmaceutical product containing 'high-immunoglobulin' components, which are neutralizing antibodies concentrated through multiple processes after mass collection of plasma from COVID-19 recovered patients, capable of neutralizing the COVID-19 virus.

GC Green Cross will evaluate the safety and efficacy in the Phase 2 clinical trial targeting 60 high-risk COVID-19 patients who have pneumonia confirmed by radiological diagnosis or are elderly or have underlying diseases.

GC Green Cross explained that since they have already produced clinical trial formulations, the drug can be administered to patients in the near future. The clinical trials will be conducted at six hospitals: Samsung Seoul Hospital, Seoul Asan Hospital, Chung-Ang University Hospital, Korea University Ansan Hospital, Chungnam National University Hospital, and Yonsei Severance Hospital.

The Ministry of Food and Drug Safety exempted the Phase 1 clinical trial for safety evaluation because the plasma, the raw material of GC5131, is derived from humans, and products applying the same principle of treating diseases using neutralizing antibodies have been developed and used previously.

As a result, there are currently a total of 16 clinical trials related to COVID-19 treatments and vaccines in Korea (14 treatments, 2 vaccines). Plasma treatments are also being developed overseas in countries such as France, China, Japan, and Italy, with six small-scale clinical trials currently underway.

This content was produced with the assistance of AI translation services.