BioDefense announces positive results from Phase II influenza trial
Oct 21, 2013 (MarketLine via COMTEX) --
BioDefense Therapeutics, or BD Tx, has announced positive results from Phase II trial of T-705a, an anti-influenza drug.
The successful completion of a Phase II double blind placebo-controlled clinical trial for the anti-influenza drug, T-705a (favipiravir), clears the way for Phase III 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 US Department of Defense (DoD)- through a contract with Boston-based MediVector, Inc.
The results of the Phase II 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.
"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."
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."
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