GC Pharma, which had been developing plasma therapy for Covid-19, said Monday that it would continue to commercialize its drug, although the U.S. National Institute of Health halted a similar process recently.
According to the Korean company, the U.S. NIH has halted clinical trials evaluating the safety and efficacy of convalescent plasma in treating emergency Covid-19 patients who developed mild to moderate symptoms.
“An independent Data Safety Monitoring Board (DSMB) met on Feb. 25 for the second interim analysis of the trial and concluded, ‘While the convalescent plasma intervention caused no harm, it was unlikely to benefit this group of patients,” GC Pharma said quoting the NIH News.
Plasma is a component of blood collected from a person who recovered from Covid-19. The therapy has been expected to be effective in patients as it contains antibodies to fight against the virus. Plasma therapy is a drug with a high concentration of neutralizing antibodies collected from recovered patients, which is different from the simple method of transfusing plasma to patients performed in NIH clinical trials.
GC Pharma, which is preparing to apply for conditional approval to the Ministry of Food and Drug Safety next month after completing phase 2 clinical trials for its plasma treatment, GC5131A, drew a line against NIH's recent announcement.
According to GC Pharma, the convalescent plasma used in the U.S. is a treatment transfusing plasma collected from cured people to Covid-19 patients, different from the plasma therapy under development in Korea.
As GC Pharma has not disclosed its clinical data, it may take some time before the company can prove its efficacy.
GC Pharma plans to submit the phase 2 trial data to obtain regulatory approval in April without presenting its study results.
“We expect our treatment to be effective as the government has approved the use of our plasma therapy on 40 occasions to treat Covid-19 patients in Korea,” an official of GC Pharma said. “We plan to draw reliable results within this month as our researchers are deriving the data from the study.”