GC Pharma finishes Covid treatment Phase 2 tests, starts compiling data
GC Pharma completed injections for Phase 2 clinical trials of its Covid-19 treatment candidate in late December, the company confirmed Wednesday.
Phase 2 clinical trials are not officially over until the data set is compiled, which the bio firm expects to complete in the first quarter of the year. GC Pharma added it would request a conditional use permit for the treatment once the Phase 2 clinical trial data arrives, likely within the first quarter, as well.
GC Pharma’s GC5131A is a plasma treatment produced with the blood of recovered Covid-19 patients. One treatment requires one blood donation. A total of 6,538 recovered people have volunteered to offer donations so far. Among them, blood has been collected from 4,126 donors.
GC Pharma has produced three batches of GC5131A, with the last batch reserved for actual use on patients individually authorized for emergency use by the government. At the moment, doctors of patients who are not benefiting from existing Covid-19 treatments can request authorization to use GC Pharma’s GC5131A.
So far, 30 patients have been permitted to be treated with the drug candidate, starting from the first case in October.
The approval granted after the submission of Phase 2 clinical trial results will make GC5131A an official treatment distributed to local hospitals. That authorization will be conditional on the basis that GC Pharma has to submit Phase 3 clinical trial data in the future.
Currently, Gilead Sciences’ remdesivir is the only official Covid-19 treatment approved for use in Korea. On Dec. 29, Celltrion submitted an application to obtain the conditional use permit for its treatment candidate CT-P59, or regdanvimab.
BY SONG KYOUNG-SON [email@example.com]
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