Public Health Emergency - Leading a Nation Prepared
The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, will sponsor the next stages of development of an antibiotic that not only holds potential as a treatment for infections from certain types of drug-resistant bacteria but also may be able to combat infections caused by bacteria used in biowarfare.
“Combating antibiotic-resistant infections is fundamental to U.S. biodefense,” explained BARDA Director Rick Bright, Ph.D. “The long hospitalizations that may be likely after a bioterrorism attack leave Americans open to secondary drug-resistant infections, which means to be prepared for bioterrorism, we need to have products available that treat antibiotic-resistant infections.”
Under a 9-month, $12 million contract with Achaogen, Inc. of San Francisco, California, BARDA will support nonclinical studies, manufacturing, and preparatory activities for a Phase 3 clinical trial of C-scape to treat complicated urinary tract infections (cUTIs).
Early testing suggests also that C-scape could provide protection against the biowarfare agents Yersinia pestis, which causes plague, and Francisella tularensis, which causes tularemia. The contract will support the study of the drug’s potential as a treatment for exposure to these agents.
The contract can be extended for up to a total of three years and $18 million to support the Phase 3 trial, manufacturing, nonclinical studies, and the preparation of regulatory filings for U.S. Food and Drug Administration approval.
The drug would be administered orally and is being developed as a two-component drug, combining an antibiotic (a beta-lactam) with a compound that inhibits certain enzymes, called Extended Spectrum Beta-Lactamases, or ESBLs. That combination should allow the antibiotic to be effective against bacterial strains that otherwise would be resistant to the drug alone.
Because bacteria that cause cUTIs are becoming resistant to other oral antibiotics, medical practitioners increasingly rely on antibiotics administered intravenously or those of last resort to treat patients with these infections. By developing alternative antibiotics, such as C-scape, doctors could rely less often on last-resort antibiotics, giving bacteria less opportunity to develop resistance to these drugs and prolonging the drugs’ effectiveness.
BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency caused by chemical, biological, radiological, and nuclear threats, pandemic influenza, emerging infectious diseases, and antimicrobial resistant pathogens.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
For more information on national public health and medical preparedness, visit www.phe.gov and to learn more about partnering with BARDA in public health preparedness visit www.medicalcountermeasures.gov.
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