Volunteers received oral doses of 250mg, 400mg or 800mg of ST-246 once a day for 21 days. The Phase I clinical trial was performed at the Orlando Clinical Research Center in Orlando, Florida.
The study was a double-blind, placebo-controlled, dose-escalating multiple dose study to assess the safety, tolerability and pharmacokinetics of the anti-orthopoxvirus compound ST-246 when administered as a single daily oral dose for 21 days in healthy volunteers in the non-fasted state.
Dennis Hruby, chief scientific officer of Siga, said: “We are very satisfied with the progress ST-246 is making in completing the studies that will be required to demonstrate safety, bio-availability and efficacy.
“We are continuing to advance our pipeline of proprietary drug candidates to treat diseases that could enter the populace through acts of bio-warfare or bio-terrorism. We believe that our progress with ST-246 will allow realization of its commercial potential and we remain encouraged with the progress of our other pipeline candidates.”