DOD announces the first patient enrolled for Phase 3 clinical trials for broad spectrum flu drug, Favipiravir

 BioDefense Therapeutics (BD Tx)—a Joint Product Management office within the U.S. Department of Defense (DoD)—announced the first patient enrolled in the North American Phase 3 clinical trials for favipiravir (T-705a). The drug is an investigational flu treatment candidate with broad-spectrum potential being developed by BD Tx through a contract with Boston-based MediVector, Inc.

Generic influenza virion
Image/CDC

Favipiravir, which was originally known by its code name, T-705, is a novel anti-viral compound that works against a different viral enzyme target than either of the approved antiviral agents used to treat people who have become ill with influenza.

Favipiravir inhibits the enzyme viral RNA polymerase, whose function is to make copies of the viral RNA segments and to synthesize mRNAs which produce the proteins that will form new viruses.​

“Favipiravir has proven safe and well tolerated in previous studies,” said LTC Eric G. Midboe, Joint Product Manager for BD Tx. “This first patient signifies the start of an important phase in favipiravir’s path to U.S. Food and Drug Administration (FDA) approval for flu and lays the groundwork for future testing against other viruses of interest to the DoD.”

In providing therapeutic solutions to counter traditional, emerging, and engineered biological threats, BD Tx chose favipiravir not only because of its potential effectiveness against flu viruses, but also because of its demonstrated broad-spectrum potential against multiple viruses. In addition to testing favipiravir in the ongoing influenza program, BD Tx is testing the drug’s efficacy against the Ebola virus and other viruses considered threats to service members. In laboratory testing, favipiravir was found to be effective against a wide variety of RNA viruses in infected cells and animals.

“FDA-approved, broad-spectrum therapeutics offer the fastest way to respond to dangerous and potentially lethal viruses,” said Dr. Tyler Bennett, Assistant Product Manager for BD Tx.

MediVector is overseeing the clinical trials required by the FDA to obtain drug licensure. The process requires safety data from at least 1,500 patients treated for flu at the dose and duration proposed for marketing of the drug. Currently, 150 trial sites are planned throughout the U.S.

Want to participate in this clinical trial?  To pre-qualify for the FAVOR study, you must:

• Be between 18 and 80 years of age
• Have a fever of at least 100.4˚F (if over 65 years of age, at least 100.0˚F)
• Have 2 or more of the following symptoms:
  • Cough, sore throat, headache, nasal congestion, body aches and pains, or fatigue

To learn more and to see if there is a participating study clinic near you, click here

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