Investigational drug, T-705a, successfully completes Phase 2 clinical trial
FORT BELVOIR, Va., Oct. 16, 2013 /PRNewswire-USNewswire/ -- The successful completion of a Phase 2 double blind placebo-controlled clinical trial for the anti-influenza drug, T-705a (favipiravir), clears the way for Phase 3 clinical trials to begin in November. The investigational drug candidate is being developed by BioDefense Therapeutics (BD Tx)—a Joint Product Management office within the U.S. Department of Defense (DoD)—through a contract with Boston-based MediVector, Inc.
The results of the Phase 2 trial showed that twice daily dosing of T-705a demonstrated statistically significant decreases in time to alleviation of each of the six influenza symptoms. In addition, subjects receiving T-705a cleared the virus statistically significantly more quickly compared to placebo. T-705a appears safe and well tolerated with no serious adverse events reported during this study. With the successful completion of an End of Phase 2 meeting with the Food and Drug Administration (FDA), MediVector is proceeding to Phase 3 clinical trials.
"We are encouraged by this important achievement; it means BD Tx is one step closer to providing the military and our nation with safe therapeutics to counter biological threats," said Lieutenant Colonel Eric G. Midboe, US Army, Joint Product Manager for BD Tx. "The rapidly evolving viral flu strains, especially the emergence of drug resistant strains, make a broad-spectrum drug solution essential in any strategy to combat this and similar biological threats."
Military planners project that a flu-like pandemic could infect nearly 10 percent of the nation's military personnel per month, significantly reducing military medical and operational capabilities. BD Tx is facilitating the advanced development of T-705a in collaboration with MediVector to enhance the nation's biodefense response capability and to help protect the military from flu pandemics. In vitro studies of T-705a show significant viral reductions against multiple flu viruses, including H1N1 (seasonal and 2009 pandemic), H5N1, H7N9, and drug-resistant flu strains.
"We are concerned with not only naturally occurring flu strains, but also those that may be biologically engineered," said Dr. Tyler Bennett, Assistant Product Manager for BD Tx. "T-705a has a unique mechanism of action that works by blocking viral RNA replication within the infected cell, giving T-705a the potential to be broad-spectrum. We intend to further test T-705a's efficacy against other viruses of interest to the DoD."
For more information, visit www.jpeocbd.osd.mil
BioDefense Therapeutics is a Joint Product Management office within the Medical Countermeasure Systems (JPM-MCS) Joint Project Management Office. A component of the Joint Program Executive Office for Chemical and Biological Defense, JPM-MCS aims to provide U.S. military forces and the nation with safe, effective and innovative medical solutions to counter chemical, biological, radiological and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance our nation's biodefense response capability.
SOURCE Medical Countermeasure Systems