WASHINGTON, Feb. 19, 2015 /PRNewswire/ -- Enrollment of 2,021 people in the Phase 3 clinical trials of a drug to treat influenza has been completed according to the Joint Project Manager for Medical Countermeasure Systems (JPM-MCS), a component of the U.S. Department of Defense's (DoD) Joint Program Executive Office for Chemical and Biological Defense. This marks a significant step for JPM-MCS and its partner, MediVector Inc., and moves the drug, favipiravir, toward U.S. Food and Drug Administration (FDA) approval as a therapeutic against influenza and potentially against other viral illnesses.
"Influenza is an enemy that does not distinguish between Warfighter or civilian, friend or foe," said Army Col. Russell E. Coleman, Joint Project Manager, MCS. "It is a consistent threat to our forces, at home or abroad, and we are very interested in the results of these promising trials."
The Phase 3 clinical trials enrolled individuals in the Americas from Canada to Argentina, and in Europe, Australia, New Zealand and South Africa. More clinics were involved than any previous DoD clinical trial. Phase 3 trials are used to confirm a drug's effectiveness and safety in a large and diverse population. In order to participate in the favipiravir trial, individuals had to present in a clinic within 48 hours of symptom onset.
Developed in partnership with MediVector Inc., a Boston-based drug development company, favipiravir works by selectively disrupting the ribonucleic acid (RNA) viral replication process within infected cells to stop the infection cycle, potentially allowing it to counter a broad spectrum of RNA viruses. It is currently approved for the treatment of drug-resistant and pandemic influenza in Japan. MCS' BioDefense Therapeutics (MCS-BDTX) selected favipiravir for advanced development due to its potential for broad-spectrum anti-viral application and the promising results of initial studies of the drug against influenza.
"We are excited about the accomplishments we have made in this enrollment period," said Army Lt. Col. Eric Midboe, Joint Product Manager, MCS-BDTX. "Favipiravir may be a significant step forward in terms of force protection for the U.S. and our allies against influenza, and has shown promise as a broad-spectrum anti-viral therapeutic."
In addition, in response to the ongoing outbreak of Ebola virus disease (EVD) in West Africa, MediVector, under contract with MCS-BDTX, is preparing to submit an Investigational New Drug (IND) application to the FDA to support clinical trials in Africa that are designed to demonstrate the safety and the antiviral activity of favipiravir against EVD.
About Joint Project Manager Medical Countermeasure Systems (JPM-MCS)
The U.S. Department of Defense's Joint Project Manager Medical Countermeasure Systems (JPM-MCS) is one of seven JPMs within the Joint Program Executive Office for Chemical and Biological Defense. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance our nation's biodefense response capability.
MCS-BDTX — a component of JPM-MCS — develops FDA-approved therapeutics that provide prophylaxis and treatment for traditional, emerging and engineered viral, bacterial and toxin biological warfare agents.
About MediVector Inc.
MediVector, Inc. is a Boston-based drug development company specializing in decreasing the time and cost of bringing drugs to market. The company complements its team's clinical development, regulatory and science expertise with proprietary processes and software based decision support systems and data management tools. MediVector's management team has a track record of successfully transforming innovative therapeutics with highly challenging clinical and regulatory hurdles into blockbuster drugs that address unmet medical needs and improve public health. For more information please visit www.medivector.com.
Favipiravir (originally known by the code name T-705) is a broad-spectrum antiviral candidate discovered in Japan by Toyama Chemical Co, a unit of Fujifilm Holdings. It is a novel compound that works by a different mechanism than approved antiviral agents used to treat people who have become ill with influenza. Favipiravir inhibits synthesis of viral RNA genomes and messenger RNAs that produce the proteins that will form new viruses. Laboratory studies indicate that favipiravir may also be effective against a variety of other RNA viruses.
In a 530 patient Phase 2 multi-center, double-blind, placebo-controlled study in the United States, twice daily dosing of favipiravir demonstrated statistically significant decreases in time to alleviation of each of the six influenza symptoms. In addition, subjects who received favipiravir cleared the virus statistically significantly more quickly compared with placebo. Favipiravir was well tolerated with no serious adverse events reported during this study.
SOURCE Joint Project Manager Medical Countermeasure Systems