GC Biopharma has announced that the Phase 2 clinical trial results for its anthrax vaccine 'BARYTHRAX inj. (GC1109)' have been published in the international journal Vaccine. BARYTHRAX is the world's first recombinant anthrax vaccine, jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA).

This randomised, double-blind, placebo-controlled Phase 2 clinical trial, approved by the Ministry of Food and Drug Safety (MFDS) was conducted to evaluate the safety and immunogenicity of the vaccine. A total of 240 healthy adult subjects were recruited across five hospitals in Korea: Seoul National University Hospital, The Catholic University of Korea St Vincent's Hospital, Korea University Ansan Hospital, Soon Chun Hyang University Hospital Seoul, and Hallym University Sacred Heart Hospital. After administration of either BARYTHRAX or a placebo, the clinical research team assessed the participants for antibody production and any adverse reactions.

The Phase 2 clinical 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.

Dr Nam Joong Kim, the principal investigator of the clinical trial and a professor at Seoul National University Hospital, stated, "This clinical research exemplifies successful academia-industry collaboration and represents a significant milestone in the development of safe and effective vaccines. We anticipate that the successful development of Korea's first recombinant anthrax vaccine will serve as a stepping stone for advancing research on infectious diseases and boosting vaccine localisation."

GC Biopharma emphasised that BARYTHRAX has the significant advantage of being more safe than traditional methods that use live attenuated bacteria and allowing for rapid mass production when needed.

"We are thrilled to have our study result published in a globally renowned academic journal Vaccine, once again recognising its clinical significance and value," said Dr Chang Kyung Kang of Seoul National University Hospital, the lead author of the publication.

Safety assessments showed that the Adverse Events (AEs) in the BARYTHRAX group, such as injection site pain, myalgia, fatigue, and malaise, were mostly mild and temporary. No cases of acute adverse reactions or deaths were reported, confirming a favourable safety profile for the vaccine.

"The clinical trial has successfully demonstrated the efficacy and safety of BARYTHRAX. This domestically developed anthrax vaccine is poised to make a significant contribution to strengthening our national pandemic preparedness," commented Jae-Uk Jeong, Head, R&D, GC Biopharma.