Public Health Emergency - Leading a Nation Prepared
An influenza antiviral medication that could work against all known flu viruses, including virus strains that are resistant to currently licensed antiviral medications, will advance in development under a contract with U.S. Department of Health and Human Services. Because influenza viruses can become resistant to medications there is a pressing need to develop new classes of influenza antiviral drugs for seasonal outbreaks and pandemics.
The 17-month, $26.5 million contract with NexBio, Inc. of San Diego to further develop their drug Fludase will be funded and overseen by the Biomedical Advanced Research and Development Authority (BARDA) in the HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR).
Fludase may prevent influenza viruses from attaching to cells so the virus cannot cause infection. Because Fludase may be effective against all known strains of influenza, the drug could be used for seasonal and pandemic influenza. Fludase also may be effective in treating parainfluenza, which causes croup, a common childhood illness. The drug would be administered directly to the respiratory tract using a simple inhalation device.
“The development of new influenza antiviral drugs with novel mechanisms of action is a renewed priority for HHS as a way to address emerging resistance to present drugs, to provide better treatment, and to increase the treatment options for doctors and patients for seasonal and pandemic influenza,” said BARDA Director Robin Robinson, Ph.D.
Under the contract, the company will conduct a clinical study in influenza-infected patients to demonstrate safety and efficacy of the drug as proof of concept for this mechanism of action. The contract also supports design of later clinical studies.
The contract is part of HHS’ implementation of the National Pandemic Influenza Preparedness Strategy, which includes accelerating the advanced development of new antiviral drugs.
The development of Fludase up to this stage was supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
BARDA, an agency within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), 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 threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza and emerging infectious diseases.
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. To learn more about HHS, visit www.hhs.gov.
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.
To learn more about ASPR, BARDA and the national influenza preparedness strategy, visit www.phe.gov. Information about influenza also is available at www.flu.gov. Follow ASPR and BARDA @phegov.
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