Intronbio Completes Final GLP-TOX Study for Anthrax Bacillus BAL200

[Asia Economy Reporter Hyungsoo Park] Intronbio announced on the 7th that it has completed the planned GLP-TOX tests for the rare disease drug candidate BAL200, which was designated as an Orphan Drug Designation (ODD) by the US FDA.

They recently completed the essential GLP general toxicity tests and safety pharmacology tests required to initiate technology export activities for BAL200. They have secured related materials such as the final test reports.

For general toxicity tests, they conducted single-dose toxicity tests on rodents, repeated-dose dose-finding tests, and repeated-dose toxicity tests on both rodents and non-rodents. Safety pharmacology tests were performed on the cardiovascular, respiratory, and central nervous systems. For non-rodent tests, primate tests were also conducted considering future technology export. In addition to safety and efficacy data, preparations for key CMC data, which are essential for subsequent development and regulatory approval processes, have been completed.

Kang Sanghyun, head of research at Intronbio, explained, "With the completion of the GLP-TOX tests and other development progress, we have secured the data and materials necessary for technology export activities. Once we obtain the efficacy test data against actual Bacillus anthracis currently being conducted through a US CRO institution, we will have all the related data for BAL200." He added, "We plan to start specific activities for global technology export and will prepare accordingly."

BAL200 is a bio-drug developed by Intronbio applying biotechnologies such as bacteriophage technology, endolysin technology, protein engineering technology, and immunology technology to respond to Bacillus anthracis. It was designated as an orphan drug by the US FDA in 2018.

When exposed to Bacillus anthracis, four FDA-approved post-exposure prophylactics (PEPs) can be used in combination with the anthrax vaccine. Treatment methods using antitoxin agents that neutralize toxins produced by Bacillus anthracis can also be used concurrently. Recently, resistant strains to existing PEPs have emerged, and since existing PEPs do not possess perfect bactericidal antibiotic properties, doubts about their effectiveness are increasing.

Yoon Kyungwon, CEO of Intronbio, said, "GLP-TOX and other tasks with overseas CROs and related companies, which were delayed due to the COVID-19 impact, are gradually normalizing. BAL200 recently completed related tests in this context."

He added, "BAL200 is a drug that can benefit from the US FDA’s Animal Rule, and we intend to highlight this advantage in pursuing technology export."