SIGA says smallpox drug candidate well-tolerated in human safety trial

By Elaine Rigoli

Tampa, Fla., July 13 - SIGA Technologies, Inc. announced that its lead smallpox drug candidate, SIGA-246, has successfully completed the first planned human clinical safety trial. Preliminary results indicate that SIGA-246 is safe and well-tolerated in human volunteers at all tested oral administered doses.

In addition, 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. The data obtained in this single-dose clinical trial will be used to support and design the upcoming multiple-dose trial," chief scientific officer Dennis E. Hruby said in a news release.

The company said SIGA-246 represents a new approach to achieve a novel, orally active, antiviral therapeutic. It has demonstrated significant antiviral activity in various animal models of poxvirus disease, including the complete protection of golden ground squirrels from lethal doses of monkeypox virus.

SIGA is a pharmaceutical company based in New York.

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