A Korean biotech called GC has applied for an investigational new drug application (IND) to conduct a Phase 2 clinical trial for a COVID-19 plasma therapy known as GC5131A. If authorized by the Korean Ministry of Food and Drug Safety, the study, which is designed to include 60 subjects, will be conducted at five trial sites, including Samsung Medical Center, Asan Medical Center, Chung-ang University Hospital, Korea University Hospital, and Chungnam National University Hospital. The sponsor seeks to establish the correct dose of the therapy and to investigate safety and efficacy.
What is GC5131A?
This is a hyperimmune globulin-based therapy produced by extracting select active immune antibodies from the plasma of those patients in Korea that have recovered from COVID-19, reports Korea Biomedical Review. This investigational product is meant to simplify the development process of delivering plasma-based therapy as hospitals in Korea are already using hyperimmune globulin to treat COVID-19 patients.
Formerly known as Green Cross Corporation, GC stated in a press release, “The production of clinical trial preparations has been completed. The first patient administration will be performed as soon as possible after the IND is approved.” The company’s medical head Kim Jin mentioned in the press release, saying, “We will do our best to put GC5131A into the medical field as soon as possible.”
About GC Pharma
GC Pharma formerly called Green Cross Corporation, is a biotechnology pioneer in South Korea. The company seeks to expand to be globally relevant player. For an overview of their products, follow the link. Research and Development (including plasma derivatives) can be viewed here.