WASHINGTON — When Project BioShield was first signed into law 15 years ago, the nation had few medical countermeasures to respond to bioterrorism.
Since then, the Biomedical Advanced Research and Development Agency has supported 27 projects using Project BioShield authorities and funding, adding 15 products to the Strategic National Stockpile. As of the middle of 2019, working with industry partners, 10 of those products had achieved Food and Drug Administration approval, while the others are available under FDA Emergency Use Authorization guidelines.
One of the biggest concerns, for the military as well as the general population, is Bacillus anthracis, the bacteria that causes anthrax. The national Centers for Disease Control has suggested it would be one of the biological agents most likely to be used, offering the following reasons:
Anthrax spores are easily found in nature, can be produced in a lab and can last for a long time in the environment.
Anthrax can be released quietly and not obviously by putting microscopic spores into powders, sprays, food and water.
Anthrax has been used as a weapon before.
In 2001, powdered anthrax spores were deliberately placed into letters that were mailed through the U.S. postal system, leading to the illness of 22 people, more than half of them mail-handlers. Five of the victims died.
That was part of the impetus for President George W. Bush to push for Project BioShield. This December, BARDA, which is part of the Department of Health and Human Services, issued a Project BioShield contract to fund the advanced development needed to support the expanded use of an existing antibiotic to treat exposure to inhalational anthrax. Technical expertise and up to $169 million over five years will be provided to Paratek Pharmaceuticals Inc. of Boston to complete any studies and manufacturing activities necessary for the FDA to consider emergency use authorization of omadacycline, marketed as Nuzyra, to treat anthrax.
The drug currently is FDA approved for the treatment of adults with community-acquired bacterial pneumonia and acute skin and skin structure infections. Nuzyra is a modernized tetracycline and a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and drug resistant strains.
In 2017, a study was published in Antimicrobial Agents & Chemotherapy gauging in vitro activity and in vivo efficacy of omadacycline against the causative pathogens of anthrax and plague, Bacillus anthracis and Yersinia pestis, respectively. The research determined that omadacycline is potent and demonstrates efficacy against both B. anthracis and Y. pestis. “The well-characterized oral and intravenous pharmacokinetics, safety, and tolerability warrant further assessment of the potential utility of omadacycline in combating these serious biothreat organisms,” according to the industry authors.1
BARDA also is supporting the following antibiotics:
Xerava, a novel, fully synthetic tetracycline antibiotic, has been approved by the FDA to treat complicated intraabdominal infections and serious Gram-negative infections, including infections caused by multidrug resistant pathogens that CDC and WHO consider to be urgent public health threats. BARDA is supporting the studies necessary for FDA to consider granting approval to use XERAVA under an Emergency Use Authorization to treat anthrax or tularemia.
Zemdri, a member of a class of antibiotics engineered to overcome the drug resistant mechanisms that cause other members of this class of drugs to fail, has been approved by the FDA to treat complicated urinary tract infections. With BARDA’s support, the company also conducted studies that could make the drug available under an FDA Emergency Use Authorization to treat the effects of biothreats like plague, tularemia, or anthrax, as well as public health threats like Carbapenem-resistant Enterobacteriacea.
Gepotidacin is the first in a new class of antibiotics that is currently in Phase 3 clinical trials for the treatment of gonorrhea and uncomplicated urinary tract infections. Gepotidacin can be administered orally or intravenously. BARDA is supporting continued development of the product and studies are underway to support its use as a medical countermeasure to treat anthrax infections.
In addition, BARDA has partnered with DOD’s Defense Threat Reduction Agency to support the development of a new oral antibiotic that could be used to treat infections caused by biothreat pathogens, including anthrax and plague, as well drug-resistant, Gram-negative infections, such as complicated urinary tract infections, that occur in hospitals and other healthcare settings. If approved, SPR994 could become the first oral antibiotic in its class.
“BARDA is committed to ensuring that Americans have access to effective antibiotics in the event of an emergency involving anthrax and during other public health emergencies in which drug-resistant bacterial infections complicate doctors’ ability to treat patients,” explained Rick Bright, PhD, director BARDA and HHS deputy assistant secretary for preparedness and response. “Saving lives after an anthrax attack on our nation means not only having FDA-approved antibiotics readily available to treat anthrax infections but also having products available to combat drug-resistant infections.”
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