South Korean pharmaceutical company GC Biopharma (KRX:006280) announced on Monday that the Phase 2 clinical trial results for its anthrax vaccine 'BARYTHRAX inj. (GC1109)' have been published in the international journal Vaccine.
BARYTHRAX, the world's first recombinant anthrax vaccine, was jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA).
Designed to assess the safety and immunogenicity of BARYTHRAX, the randomised, double-blind, placebo-controlled Phase 2 clinical trial enrolled a total of 240 healthy adult subjects across five hospitals in Korea. Following the administration of either BARYTHRAX or a placebo, the research team evaluated the subjects for antibody production and any adverse reactions.
According to GC Biopharma the trial demonstrated that the vaccine elicited antibodies that neutralised the anthrax toxin at a level exceeding the pre-defined protective threshold. This finding indicates robust immunogenicity and suggests that BARYTHRAX can provide clinically meaningful protection against anthrax infection, the company said.
Injection site pain, myalgia, fatigue, and malaise, were mostly mild and temporary. There were no cases of acute adverse reactions or deaths, confirming a favourable safety profile for the vaccine.
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