The USA's SIGA Technologies says that its lead smallpox drug candidate, SIGA-246, has successfully completed the first planned human clinical safety trial. According to the New York-based firm, preliminary results indicate that the agent is "safe and well-tolerated" in human volunteers at all tested oral doses. In addition, data from blood level exposure was sufficient to support once-daily dosing.
Dennis Hruby, SIGA's chief scientific officer, said that the data obtained from this Phase I double-blind, randomized, placebo-controlled, ascending single-dose study will be used to support and design the upcoming multiple-dose trial.
The US drugmaker believes that SIGA-246 is the most advanced smallpox treatment currently in development, representing a new approach towards an orally-active, antiviral therapeutic.
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