Researchers from The University of Texas (UT) at Austin successfully concluded years of research when the anthrax antitoxin, called obiltoxaximab, they designed for the treatment and prevention of inhaled anthrax was approved by the U.S. FDA on March 21.
The molecule was partially developed at UT Austin before the researchers licensed the drug to New Jersey-based Elusys Therapeutics for further development. The drug will now start to be sold under the name Anthim.
The FDA approval is for the administration of obiltoxaximab for inhalational anthrax as a combined therapy with appropriate antibacterial medicines, and its administration as a prevention therapy when alternatives are not available or are not applicable.
The UT research team started working on an anthrax antitoxin a decade ago. The team was successful in designing and developing Anthim as a high-affinity, “sticky” antibody fragment that binds to the anthrax toxin, blocking its activity, as explained in detail in a related UT Austin news release in 2005.
The UT Austin team includes three members of the faculty: Brent Iverson, who serves as dean of undergraduate studies and is a professor in the Department of Chemistry; George Georgiou, professor in the departments of chemical engineering, biomedical engineering, and molecular biosciences; and Jennifer Maynard, associate professor in the McKetta Department of Chemical Engineering. The research team also had the assistance of a Texas Biomedical Research Institute scientist, Jean Patterson.
“This is a perfect example of how the latest cutting-edge tools and technologies being developed on academic campuses can rapidly provide unique and powerful solutions to emerging problems of national interest,” Iverson said in a press release.
Inhalational anthrax is an uncommon condition that can manifest itself after a person was exposed to animals that were infected, or through contact with contaminated animal products. Anthrax spores can be also be released as an intentional act. The condition develops due to the inhalation of spores of the anthrax batercia Bacillus anthracis, which then grows inside the body while simultaneously releasing toxins that might cause irreversible tissue damage and even death.
Anthrax has been used as a bioterrorism threat due to its spores’ resistance to treatments and the ease in which the bacteria can spread simply by being released into the air.
In 2001, at least 15 people were infected with anthrax in the weeks after the 9/11 attacks, and five of them did not resist the infection. The U.S. government agreed with Elusys to stockpile Anthim as a reserve for any future outbreaks.
It should be noted that University of Texas did not allow any live anthrax bacteria to enter the campus in order to develop the drug. Obiltoxaximab was tested for its effectiveness in animals before FDA approval, and its safety was confirmed in healthy human volunteer participants.
“Academic research can address real-world needs and partner with industry to develop a product, and universities are able to respond rapidly to needs as they arise, assigning graduate students to the project with greatest urgency,” said Maynard, who participated in most of the research while still a graduate student. “This approach has the added advantage of training the next generation of scientists.”