Local therapy for Covid-19 starts Phase 2 trialsThe Ministry of Food and Drug Safety approved a second-phase clinical trial of a Covid-19 treatment by pharmaceutical firm GC Pharma on Thursday.
The substance, dubbed GC5131, is a type of hyper-immune globulin drug that uses blood plasma taken from people who have fully recovered from Covid-19 infections. The concept is different from plasma therapy, which transfuses the plasma of a recovered patient directly into another patient.
GC Pharma is the government’s sole partner in developing a hyper-immune globulin drug to combat the pandemic.
The drug safety watchdog gave the green light to administer the treatment to 60 Covid-19 patients to evaluate its safety and efficacy. The ministry said it skipped the Phase 1 clinical trial after evaluating the widely recognized safety profile of a hyper-immune globulin drug.
People who have recovered from Covid-19 develop natural defenses against the disease in their blood. Antibodies are found in the part of the blood called plasma. According to GC Pharma, hyper-immune globulin drugs have been long used to treat other diseases, and because GC5131 follows the same action mechanism and production technology, it was able to be cleared for Phase 1 trials.
So far, clinical trials for 14 Covid-19 treatments and two vaccines are under way in Korea. GC5131 is the first candidate on the list to receive a nod to undergo second-phase trials and was not a commercialized drug.
According to GC Pharma, the batch of drugs required to undergo trials has already completed production. The company started manufacturing it last month after it secured abundant blood plasma donations from recovered patients.
BY YONHAP, SONG KYOUNG-SON [firstname.lastname@example.org]