An influenza countermeasure, backed by the U.S. Department of Defense Joint Project Manager Medical Countermeasure Systems (JPM-MCS), has successfully enrolled over 2,000 patients in two Phase 3 studies in adults with uncomplicated influenza.
The drug favipiravir, made by MediVector, Inc., is an orally administered novel anti-viral compound with a unique mechanism of action that is active against a broad range of RNA-based viruses.
Favipiravir inhibits synthesis of viral RNA genomes and messenger RNAs that produce the proteins that will form new viruses.
“We are pleased with the rapid enrollment of these clinical trials, and are hopeful the results will reinforce the promise seen in earlier studies,” said Lieutenant Colonel Eric G. Midboe, US Army, Joint Project Manager for BioDefense Therapeutics. “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 randomized, double-blind, placebo-controlled, multi-centered Phase 3 FAVOR studies are evaluating the time to alleviation of all primary influenza symptoms consistent with uncomplicated influenza, after treatment with favipiravir. Primary symptoms include cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue. Additional outcome measures include reduction in virus and safety.
Favipiravir is orally administered for five days, with a higher dosage level on day one. The first study includes patients (1161) from the Americas and the second study includes patients (860) from the United States, Europe, Australia, New Zealand and South Africa. Data review is ongoing and study reports will be provided to the FDA once complete.
“Completion of enrollment within a year of initiating these clinical trials is a significant accomplishment, and the resulting data from the carefully designed studies will lay the groundwork for filing an application for approval to market favipiravir in the U.S.,” Dr. Carol Epstein, Executive Vice President and Chief Medical Officer of MediVector, Inc. said.
Currently there are three FDA-approved anti-viral drugs for treating influenza, oral Tamiflu® (oseltamivir), inhaled Relenza® (zanamivir) and intravenously-administered Rapivab® (peramivir).
“Resistance to currently available influenza treatments is a growing problem,” states Epstein. “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.”
In Nov. 2014, MediVector was additionally awarded $30 million by the DoD for studies testing favipiravir as a potential anti-viral treatment for Ebola.