SIGA's lead smallpox drug SIGA-246 gets IND approval to begin phase 1 trials

By E. Janene Geiss

Philadelphia, Dec. 13 - SIGA Technologies, Inc. said Tuesday that the Food and Drug Administration accepted its Investigational New Drug Application to begin phase 1 clinical trials of SIGA-246, its lead smallpox drug.

To expedite the program, the FDA granted it fast-track status, according to a company news release.

SIGA said it will start phase 1 trials to evaluate SIGA-246 in healthy volunteers at the Biodefense Clinical Research Branch of the National Institute of Allergy and Infectious Diseases, which is part of the federal government's National Institutes of Health.

The primary objective of the study will be to evaluate the safety and tolerability of single escalating doses of SIGA-246, officials said.

SIGA-246, an orally active compound, 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.

Smallpox virus, classified as a category A agent by the Center for Disease Control, is considered one of the most significant threats for use as a biowarfare agent. It is easily transmissible from person to person, is hardy in the environment, and can be readily delivered.

"A phase 1 clinical trial of SIGA-246 is a critical step toward insuring the availability of a smallpox drug that can fight this dreaded disease without serious side effects. This nation needs a self-administrable antiviral drug in order to provide immediate protection in the event of the deliberate release of smallpox virus. Based upon the data generated to date, we believe that SIGA-246 will be a safe and effective drug for the treatment of smallpox," Dennis E. Hruby, SIGA's chief scientific officer, said in the release.

SIGA, based in New York City, is applying viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense.

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