Public Health Emergency - Leading a Nation Prepared
Author: Brian Tse, PhD, Project Officer, BARDA Antimicrobial Medical Countermeasures Branch, and Mark Albrecht, PhD, Acting Chief, BARDA Antibacterial Medical Countermeasures Branch Published Date: 8/27/2018 5:41:00 PM
Category: Medical Countermeasures;
In 1954, Alexander Fleming, who discovered penicillin, began warning against the potential for bacteria to become resistant to the new antibiotic. Just over a decade later, in July 1968, physicians documented the first human case of a superbug known as MRSA, Methicillin-resistant Staphylococcus aureus. Fast forward 50 years, and MRSA has become just one of many drug-resistant infections healthcare providers and patients battle every day.
Back in the 1950s and 60s, drug manufacturers were developing an array of new antibiotics so resistance did not seem important because health care providers could turn to an alternate drug. Today, antibiotics are over-prescribed and improperly used, which can increase the number of resistant infections. In addition, few alternative drugs capable of overcoming antibiotic resistance are available because most manufacturers have abandoned antibiotic development in favor of products that provide a greater return on investment. The result is a public health crisis and a national security risk.
Antibiotic development, a national health security measure
As it was designed to do, BARDA stepped in to turn around that narrative. The nation faces health security threats from bacteria that could be weaponized, such as anthrax, and much like hospital and community acquired bacteria, these bioweapons can become resistant to antibiotics either naturally or through bioengineering. In addition, the illnesses or injuries caused by all national security threats can lead to secondary bacterial infections, and those secondary infections can be antibiotic-resistant superbugs, like MRSA, pneumonia, or complicated urinary tract infections. New antibiotics are among the nation’s most powerful weapons in the battle against these and other antibiotic resistant threats to ensure national health security.
Since 2010, BARDA has worked with 12 private companies on developing 15 new antibiotics, and already three have earned approval by the U.S. Food and Drug Administration. These approvals, among the 40 approvals of BARDA-sponsored medical countermeasures, mark critical milestones in our nation’s health security preparedness.
Driving innovative new products at a break-neck pace
The most recent FDA approval came for XERAVA (eravacycline), a novel, fully synthetic tetracycline antibiotic, developed by Tetraphase Pharmaceuticals in partnership with BARDA and another company called CUBRC. FDA approved the drug to treat complicated intra-abdominal infections; the antibiotic also could be used against serious Gram negative infections, including infections caused by multi-drug resistant pathogens that the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) consider to be urgent public health threats.
The company also conducted BARDA-supported studies necessary for FDA to consider Emergency Use Authorization to use XERAVA in treating anthrax or tularemia.
Another FDA approval came earlier this summer for an intravenous drug called ZEMDRI (plazomicin) to treat complicated urinary tract infections. ZEMDRI is a member of a class of antibiotics engineered to overcome the drug resistant mechanisms that cause other member of this class to fail.
Achaogen, maker of ZEMDRI, had worked with BARDA’s advanced research and development program on earlier development of the drug and, in August 2010, became the first company to collaborate with BARDA’s antibacterials medical countermeasures program to develop new antibiotics.
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 CRE. BARDA and Achaogen continue to work on another drug that, if successful, could reduce the use of antibiotics for certain types of infections and, ultimately, could reduce the number of drugs to which CRE is resistant.
The first product ever approved in BARDA’s antimicrobial medical countermeasures program, VABOMERE (carbavance), earned FDA approval in 2017 to treat complicated urinary tract infections and a kidney infection called pyelonephritis in adults. The antibiotic is a combination drug composed of a commercially available, best-in-class antibiotic, called meropenem and a novel, first-in-class, beta-lactamase inhibitor called Vaborbactam. BARDA’s partner, The Medicines Company, also conducted studies that show the drug also is effective against Gram-negative bacteria such as Carbapenem-resistant Enterobacteriacea (CRE), which tops the CDC’s and WHO’s list of antibiotic resistant infections that threaten public health.
Currently, the BARDA antibacterials portfolio includes a mix of early and late-stage products with an emphasis on Phase 3 advanced clinical development in humans. Two companies recently joined BARDA on antibiotic development. One is Spero, with an oral carbapenem antibiotic to treat complicated urinary tract infections. Spero, BARDA and the Defense Threat Reduction Agency are collaborating to evaluate the product against five biothreats. The other is Summit, with a treatment for Clostridium difficile infections (CDI). Patients can develop CDI while being treated with antibiotics for prolonged periods after an anthrax exposure.
Efforts by BARDA and its industry partners now span the majority of pathogens called out in CDC’s 2013 Antibiotic Resistance Threats Report as urgent or serious threats to public health. BARDA also is working with international partners through CARB-X to fund initial development of antibiotics and diagnostics. Most recently, BARDA has launched a program called DRIVe to tackle systemic problems like sepsis and develop methods to detect illness before people even realize they are sick.
The majority of the antimicrobial products BARDA and its partners are working on also are designed to treat infections caused by biodefense pathogens and potentially to be used in an emergency. By earning FDA approval to treat day-to-day infections that threaten public health, these products become familiar to healthcare providers, giving healthcare providers another tool to combat resistant bacteria including biodefense pathogens. Because they are available on the commercial market, they would be easily accessible in a mass exposure to a biothreat while requiring little or no stockpiling at taxpayer expense. BARDA’s funding and expertise also decrease corporate development costs, which for a marketable product can translate into a greater return on investment for the developers.
BARDA continues to collaborate with industry to make more options available for treating infections caused directly by biological weapons, as well as for treating the life-threatening secondary infections that can follow, adding new ammunition to the battle against antibiotic resistant bacteria. Learn more about what partnership opportunities are available through the Broad Agency Announcement (BARDA-CBRN-BAA-11-100-SOL-00009 at www.fbo.gov).
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