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HHS awards contract for advanced development of novel flu treatment
New antiviral could counter growing problem of antiviral resistance to existing influenza drugs

​​​​​A new drug to help address the growing problem of antiviral drug resistance and add to the tools available to fight pandemic and seasonal influenza will be developed under a contract awarded today by the U.S. Department of Health and Human Services. The $44 million, 33-month contract with Romark Laboratories of Tampa, Fla., supports advanced development of Nitazoxanide to treat influenza in adults and teens.

Antiviral drug resistance poses a greater threat in a pandemic. Influenza viruses have become resistant to two of the four drugs approved to treat the flu, and resistance has begun to emerge to the remaining two drugs.

Nitazoxanide is approved in the United States to treat two waterborne parasites, Giardia lamblia and Cryptosporidium parvum, in adults and children. Previous studies with Nitazoxanide have shown promising results in treating strains of influenza that are resistant to currently approved antiviral medications.

The drug has a unique mechanism of action that targets a process in the body’s cells needed by the virus rather than targeting the virus itself as other antiviral drugs do. Targeting these cells rather than the influenza virus reduces the risk that the virus will develop resistance against this drug.

In laboratory experiments, Nitazoxanide has also shown potential against other non-influenza respiratory viruses that cause disease in people and thus may have broad spectrum applicability.

“This new antiviral candidate is a step toward our goal to make new types of treatments available for influenza,” said Robin Robinson, Ph.D., director of HHS’ Biomedical Advanced Research and Development Authority, which will manage and fund the contract. “Repurposing an existing drug with a proven safety record that can work in combination with other approved treatments is a key strategic goal and would greatly enhance our nation’s domestic response capabilities for pandemic and seasonal influenza.”

Under the contract, Romark will conduct the final studies needed for U.S. Food and Drug Administration approval of the drug for influenza treatment. The studies include a Phase 3 clinical trial to evaluate Nitazoxanide alone and in combination with an approved influenza antiviral drug to treat uncomplicated influenza infection in people ages 13 to 65.

Nitazoxanide is the fourth antiviral drug candidate under development in BARDA’s pandemic influenza program and the second in development that focuses on a host target as a mechanism of action rather than a conventional approach toward a viral target. Having drugs available that focus on a host target is a goal for national pandemic preparedness.

BARDA’s pandemic influenza program also supported advanced development of Flucelvax, the first cell-based influenza vaccine in the United States to earn FDA approval, and FluBlok, the first FDA-approved influenza vaccine to use recombinant DNA technology.

Within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), BARDA develops and procures medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

For more information about BARDA and the advanced research and development of medical countermeasures, visit www.medicalcountermeasures.gov. Contract opportunities and awards are announced at www.fbo.gov.

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 and to keep up to date on flu, visit www.flu.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 and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov.