Public Health Emergency - Leading a Nation Prepared
To combat potentially deadly Clostridium difficile infections that can occur in patients being treated for bacterial infections including anthrax, tularemia and other biothreats, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) is partnering with Summit Therapeutics on late-stage development of a new antibiotic.
“To save lives from biothreats, whether it’s anthrax or tularemia, doctors must be able to treat not just the biothreat itself but also opportunistic secondary infections that may occur,” explained Biomedical Advanced Research and Development Authority (BARDA) Director Rick Bright, Ph.D. “We are continually seeking innovative ways to protect health from all biodefense threats. Partnering to develop drugs that treat biothreats as well as common, serious infections has proven to be an innovative, sustainable business model for industry and the federal government.”
To develop the new drug, BARDA, a component of ASPR, will provide up to approximately $32 million over two years to Summit Therapeutics, headquartered in Oxford, UK, to conduct two Phase 3 human clinical studies of its drug Ridinilazole. The contract potentially provides up to a total of $62 million over five years.
In addition to the two Phase 3 studies, the company will manufacture the drug for testing and conduct all regulatory activities involved in taking the drug to market. Under the cost-sharing arrangement with BARDA, Summit Therapeutics will provide a significant portion of the funding needed for the development and regulatory approval of Ridinilazole.
Ridinilazole is an orally administered small molecule antibiotic that exhibits a narrow spectrum of activity against Clostridium difficile. Ridinilazole has received Qualified Infectious Disease Product (QIDP) designation and has been granted Fast Track designation by the U.S. Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.
Clostridium difficile infections, known as CDI, occur most often in patients following the prolonged use antibiotics because such use can kill the human body’s natural gastrointestinal flora and allow overgrowth of Clostridium difficile bacteria. Anthrax and tularemia infections require 60 days or more of treatment with antibiotics, putting patients at risk for CDI.
Clostridium difficile bacteria produce toxins causing inflammation in the colon and severe diarrhea, which, in the most serious cases, can be fatal. According to a 2013 report from the Centers for Disease Control and Prevention,thesebacteria cause nearly half a million infections and 15,000 deaths each year in the United States, posing an urgent public health threat.
BARDA takes a comprehensive integrated portfolio approach to advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. In addition to emerging infectious diseases, these threats include pandemic influenza, chemical, biological, radiological, and nuclear agents, and antimicrobial resistant pathogens.
ASPR partners with other federal agencies, in particular the National Institutes of Health, as well as private industry to develop medical products needed to minimize the health effects of disasters and other public health emergencies. Potential products may transition from basic research and early clinical trials at NIH to BARDA for support of the advanced development necessary to support approval or licensure by the FDA.
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 lead 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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