This randomized, 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 neutralized 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.
In addition, safety assessments showed that the adverse events in the BARYTHRAX group, such injection site pain, myalgia, fatigue, and malaise, were mostly mild and temporary. No cases of acute adverse reactions or deaths were reported, confirming a favorable safety profile for the vaccine.
GC Biopharma emphasized 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.
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."
He added, "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 localization."
"We are thrilled to have our study result published in a globally renowned academic journal Vaccine, once again recognizing its clinical significance and value," said Dr. Chang Kyung Kang of Seoul National University Hospital, the lead author of the publication.
Barythrax Inj.
This vaccine is the world's first recombinant protein-based anthrax vaccine and Korea's 39th New Drug and 3rd New Drug Vaccine.
The vaccine is produced using recombinant technology to express and purify solely the Protective Antigen (PA) protein from Bacillus anthracis, the key component of the anthrax toxin.
Anthrax
Anthrax is a zoonotic disease that can infect both humans and animals. It is classified as a potential bioterrorism agent as the aerosolized anthrax spores can cause fatal respiratory infections.
About GC Biopharma
GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo™(intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation).
For more information please visit https://www.gcbiopharma.com/eng/
