Defense Department-based influenza drug enters Phase 3 study

The U.S. Department of Defense Joint Project Manager Medical Countermeasure Systems has enrolled 2,000 patients in two Phase 3 influenza studies. | U.S. Department of Defense JPM-MCS
About 2,000 individuals have enrolled in two Phase 3 studies for an influenza drug that is backed by the Department of Defense Joint Project Manager Medical Countermeasure Systems.

Made by MediVector, Inc., the drug is called favipiravir.

“We are pleased with the rapid enrollment of these clinical trials, and are hopeful the results will reinforce the promise seen in earlier studies,” Lt. Col. Eric Midboe, joint project manager for BioDefense Therapeutics, said. “Favipiravir may represent an important new therapeutic to protect our military and nation when a vaccine fails to protect against an emerging influenza strain, a drug resistant influenza, and other RNA-virus threats.”

The double-blind study will evaluate the time to alleviate primary flu symptoms after patients are given favipiravir. Symptoms include a sore throat, headache, cough, nasal congestion, fatigue, body aches and pains.

The drug will be given for five days with a higher dose given on the first day. In the first study, all 1,161 patients will be from the Americas. The second study will include 860 people from the U.S., Europe, Australia, New Zealand and South Africa.

“Resistance to currently available influenza treatments is a growing problem,” MediVector executive vice president and chief medical officer Carol Epstein said. “There is an urgent need for a new broad-spectrum therapeutic with a different mechanism of action that is active against multiple strains of influenza viruses.”

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