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news.Siga Technologies' lead smallpox drug candidate, SIGA-246, has successfully completed its first planned human clinical safety trial, with preliminary results indicating that the drug is safe and well-tolerated in human volunteers at all tested doses.
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The company further revealed that data from blood level exposure was sufficient to support once-a-day dosing.
“We are very pleased with the outcome of the drug’s first human clinical trial. The data from the trial and the absence of significant side effects reinforces our belief that SIGA-246 will not only be a potent therapeutic drug against smallpox, but a safe and reliable one as well,” said Dr Dennis Hruby, chief scientific officer of Siga.
The company will now use the data it has gathered from this initial trial to support its upcoming multiple dose trial.
Siga believes that SIGA-246 is the most advanced smallpox treatment currently in development. The compound represents a new approach to achieve a novel, orally active, antiviral therapeutic.
The drug has demonstrated significant antiviral activity in various animal models of poxvirus disease, including the complete protection of golden ground squirrels from lethal doses.