SIGA Technologies, Inc. has announced that it has successfully completed a multiple ascending dose human clinical trial with its lead smallpox drug candidate, ST-246. Volunteers received oral doses of 250 mg, 400 mg or 800 mg of ST-246 once a day for 21 days.
“The results of our second clinical trial with ST-246 appear to support our belief that ST-246 will be a safe, reliable and effective therapeutic drug against smallpox. While final study reports are not yet available, un-blinding of the data indicates the drug is safe and well tolerated with no observed serious adverse effects,” said Dr. Eric A. Rose, Chief Executive Officer of SIGA Technologies.
Dr. Rose continued, “The data that was revealed is consistent with previous results and will be an important component of our new drug application seeking FDA marketing approval. We also believe the data we have now acquired reasonably establishes that the safety profile of the drug compares favorably to the 20-30 percent mortality of symptomatic smallpox and supports eligibility of the drug for emergency use authorization in the event of an outbreak.”
“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,” said Dennis E. Hruby, Chief Scientific Officer of SIGA Technologies.
Dr. Rose added, “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.”
SIGA believes that ST-246 is the most advanced smallpox treatment currently in development. It has demonstrated significant antiviral activity in various animal models of poxvirus disease, including the complete protection of primates from lethal doses of monkeypox and smallpox virus.
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. A total of 30 participants were enrolled for the study. At each dose level eight participants received active compound and two received a placebo.