BioDefense Therapeutics enrolls first patient for favipiravir Phase 3 clinical trials

BioDefense Therapeutics said on Tuesday that its first patient for the North American Phase 3 clinical trials for favipiravir, and investigational treatment for flu, has been enrolled.

Favipiravir is a new antiviral compound that selectively disrupts the virus' replication and transcription of RNA and stops the infection cycle.

"Favipiravir has proven safe and well tolerated in previous studies," Lt. Col. Eric Midboe, joint product manager for BD Tx, said. "This first patient signifies the start of an important phase in favipiravir's path to U.S. Food and Drug Administration approval for flu and lays the groundwork for future testing against other viruses of interest to the [Department of Defense]."

BioDefense Therapeutics is a joint product management office within the U.S. Department of Defense. The new treatment is being developed by BD Tx through a contract with MediVector, Inc.

Favipiravir was selected because it has potential effectiveness against multiple viruses. BD Tx is testing the drug on Ebola virus and others that are considered threats to the military.

"FDA-approved, broad-spectrum therapeutics offer the fastest way to respond to dangerous and potentially lethal viruses," Tyler Bennett, the assistant product manager for BD Tx, said.

MediVector is directing the FDA-required clinical trials. Safety data from at least 1,500 patients who have been treated for flu at the recommended dose and duration is required to obtain a drug license. In the U.S., 150 trial sites are planned.

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U.S. Department of Defense

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