Public Health Emergency - Leading a Nation Prepared
The U.S. Department of Health and Human Services will sponsor development of a novel therapeutic to treat smallpox infections. The variola virus, which causes smallpox, was eradicated but remains a potential health security threat. The development of vaccines and therapeutics to prevent and treat smallpox infections remains a long-standing U.S. biodefense goal and commitment to the international community.
Under the agreement announced today, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will work with BioFactura, Inc., of Frederick, Maryland, providing expertise and $9.5 million over two years to develop a monoclonal antibody treatment for smallpox. BARDA has options to support additional work, providing up to a total of $67.4 million over five years.
BioFactura is developing a treatment that uses multiple monoclonal antibodies, a combination known as a monoclonal antibody cocktail. Monoclonal antibodies bind specific proteins on the virus to neutralize it, decreasing the amount of the virus in the body that the immune system must fight. Testing in non-clinical studies showed that the antibody cocktail neutralizes the variola virus, which causes smallpox and related viruses.
“We recognize the possibility that smallpox virus samples may exist outside of two approved laboratories in the world, especially as biotechnology continues to advance. Together, these factors mean we face the unsettling possibility that the virus could be released accidentally or intentionally,” said BARDA Director Rick Bright, Ph.D. “An additional option to treat people exposed to the variola virus would provide an additional tool for both doctors and patients, helps guard against potential drug resistance should a smallpox outbreak occur, and fulfills a critical goal for U.S. and global health security.”
Under the contract, BioFactura will conduct non-clinical studies needed for final product formulation and to determine the appropriate treatment dose. BARDA may also support manufacturing to meet Good Manufacturing Practices, additional non-clinical studies and Phase 1 clinical safety trials in healthy patients, all of which will be required as the program works toward requesting U.S. Food and Drug Administration (FDA) approval.
If successful, the therapeutic could become only the second treatment option for smallpox infections to achieve FDA approval. BioFactura’s therapeutic treatment employs works differently than TPOXX, the first FDA-approved smallpox treatment.
Smallpox was once one of the deadliest infectious diseases, infecting approximately 50 million people a year and killing an estimated 300 million people worldwide in the 20th century alone.
Because routine smallpox vaccination ended in the United States in the early 1970s, people born after that time are not immune to the disease. The World Health Organization (WHO) declared the disease eradicated worldwide in the 1980s after a decades-long, global public health campaign that relied on vaccination. The variola virus remains in two high-containment laboratories, one in the United States and one in Russia, which are approved by the WHO to use the virus for limited research.
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 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 and transform health security. For more, visit www.phe.gov. To learn more about partnering with BARDA, visit www.medicalcountermeasures.gov.
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