The successful completion of a Phase 2 double-blind, placebo-controlled clinical trial for the anti-influenza drug T-705a clears the way for Phase 3 clinical trials to begin in November.
Through a contract with Boston-based MediVector Inc., the investigational drug candidate is being developed by BioDefense Therapeutics, a joint product manager within the Medical Countermeasure Systems Office, a component of the Defense Department’s Joint Program Executive Office for Chemical and Biological Defense.
The results of the Phase 2 trial found that twice daily dosing of T-705a demonstrated statistically significant decreases in each of the six influenza symptoms, officials said. In addition, subjects receiving T-705a cleared the virus significantly quicker compared to the placebo, and the drug appears safe and well tolerated, with no serious adverse side effects reported during the study.
“We are encouraged by this important achievement. It means [BioDefense Therapeutics] is one step closer to providing the military and our nation with safe therapeutics to counter biological threats,” said Army Lt. Col. Eric G. Midboe, joint product manager.
“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 medical and operational capabilities. BioDefense Therapeutics 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, officials said.
In vitro studies of T-705a show significant viral reductions against multiple flu viruses, including seasonal and 2009 pandemic H1N1, H5N1, H7N9 and drug-resistant flu strains, they added.
“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 BioDefense Therapeutics.
“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.”
Read more about the drug candidate at PubMed.gov: T-705 (favipiravir) induces lethal mutagenesis in influenza A H1N1 viruses in vitro.
