IntronBio Confirms Efficacy of Rare Drug BAL200 Against Bacillus anthracis

[Asia Economy Reporter Hyungsoo Park] Intronbio announced on the 29th that ‘N-Rephasin BAL200’ (hereafter BAL200), a bio-pharmaceutical for treating anthrax infection based on endolysin, has demonstrated excellent efficacy in multiple efficacy evaluation tests against anthrax bacteria.

A company official stated, "The test results sufficiently demonstrate the potential of BAL200," and added, "We are now able to initiate animal test designs in accordance with the animal efficacy rule."

Intronbio conducted preliminary efficacy evaluation tests against anthrax bacteria at a specialized facility in the United States under the animal efficacy rule. In the evaluation tests, BAL200 confirmed antibacterial activity that eradicated all 10 or more strains of bacteria, including the ‘Ames’ anthrax strain, which is notorious for being used in white powder letter terrorism. It showed rapid bactericidal properties at a level not demonstrated by existing antibiotics.

Unlike the widely used anti-toxin agents currently employed as anthrax countermeasures, BAL200 is a fundamental therapeutic drug that directly eliminates the anthrax bacteria itself, which can be considered the source of infection. It can deliver faster therapeutic effects than existing antibiotic treatments, making it suitable for treating anthrax infections characterized by rapid disease progression.

BAL200 is a new bio-drug developed by Intronbio by applying various technologies such as bacteriophage technology, endolysin technology, protein engineering, and immunology. It was designated as an orphan drug by the U.S. Food and Drug Administration (FDA) in 2018.

The orphan drug designation is one of the support policies established by the U.S. FDA to expand treatment opportunities for patients suffering from rare diseases. When designated as an orphan drug, developers receive several benefits including expedited clinical trial approval and authorization periods, seven years of marketing exclusivity, exemption from prescription drug application fees, and tax reductions.

Yoon Kyungwon, CEO of Intronbio, said, "For BAL200, we are aiming for early technology export," and added, "Our primary goal is to secure efficacy and safety data for this purpose." He also noted, "In this regard, multiple tests including GLP-TOX (non-clinical toxicity tests) are being conducted at specialized institutions both domestically and internationally."