Public Health Emergency - Leading a Nation Prepared
To combat deadly infections caused by drug-resistant bacteria or bioterrorism agents, the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) will partner for the first time with the Defense Threat Reduction Agency (DTRA) and Spero Therapeutics Inc. of Cambridge, Massachusetts, to develop a drug that could become the first oral antibiotic in its class.
The antibiotic, SPR994, holds potential as a treatment for infections caused by biothreat pathogens, including anthrax and plague, as well as a treatment for drug-resistant, Gram-negative infections, such as complicated urinary tract infections, that occur in hospitals and other healthcare settings.
To develop the drug, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide up to $15.7 million over three years to Spero Therapeutics to conduct studies necessary for drug characterization, drug manufacturing, and to test efficacy. BARDA could provide up to a total of $44.2 million over five years if all project milestones are met.
In addition to BARDA-supported work, DTRA will support non-clinical studies to test SPR994 against the five priority biothreat pathogens at the United States Army Medical Research Institute of Infectious Diseases. All five of the bacteria can cause deadly infections, including melioidosis, glanders, tularemia, plague and anthrax.
Spero Therapeutics will support the remainder of the studies needed to bring the drug to market, including a planned pivotal Phase 3 clinical trial to treat complicated urinary tract infections. Spero also will spearhead all regulatory activities needed to seek U.S. Food and Drug Administration approval of SPR994.
“Antibiotic resistance is a growing threat to our national health security as well as to global health,” explained BARDA Director Rick Bright, Ph.D. “This project brings together partners with unique expertise to focus on a common goal: protecting health on a daily basis and saving lives in an attack involving some of the most serious biological threats our country faces.”
If the development work is successful, SPR994, a small molecule drug, may become the first oral antibiotic in a class of drugs known as carbapenem antibiotics. Early studies of SPR994 showed promise in treating all five biodefense pathogens as well as life-threatening Gram-negative bacteria, such as complicated urinary tract infections, resistant to antibiotics.
According to a 2013 Centers for Disease Control and Prevention report on antibiotic resistance, at least 2 million people each year in the United States become infected with bacteria that are resistant to antibiotics and at least 23,000 people die as a direct result of these infections, costing the healthcare system $35 billion annually.
If successful, this therapy also would increase treatment options for patients with Gram-negative infections, potentially reducing the cost and complications associated with extended hospital stays. The availability of an oral drug would improve the U.S. government’s response to a public health emergency since a large number of patients could be treated in outpatient settings, such as clinics, avoiding the need to administer drugs intravenously in a hospital.
ASPR works daily with other federal agencies, including Department of Defense and the National Institutes of Health (NIH), and private industry to develop medical products needed to minimize the health effects of disasters and other public health emergencies. Typically, potential products for civilian use transition to BARDA for support of the advanced development necessary to support approval or licensure by the FDA after basic research and early clinical trials at DoD or NIH.
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.
For more about ASPR and BARDA, visit www.phe.gov/aspr and to learn more about partnering with BARDA in public health preparedness, visit www.medicalcountermeasures.gov.
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