The Defense Threat Reduction Agency’s Joint Science and Technology Office, along with the U.S. Army Medical Research Institute of Infectious Diseases, announced this week that a compound demonstrated no adverse effects in its Phase 1 trials against the Ebola virus.
The compound, GS-5734, manufactured by Gilead Sciences, is scheduled for additional testing in Phase 1b — a multiple ascending dose study. If the compound demonstrates positive results, the U.S. Department of Defense and Gilead will seek approval from the U.S. Food and Drug Administration (FDA) as early as 2017.
As a standard for all countermeasures, the treatment must work prior to and post exposure. Additionally, it must be able to be manufactured quickly in emergency surge situations and gain regulatory approval from the FDA.
Prior to human testing, the treatment was tested on primates and demonstrated 100 percent protection, even when administered up to three days after exposure. Several product candidates were considered prior to testing, however, GS-5734 demonstrated the qualities needed to go ahead with testing.
The treatment is part of the polymerase inhibitor family of compounds. Polymerase enzymes are usually responsible for replicating the Ebola virus. By inhibiting their replication, the virus is not able to spread.