Development of the small-molecule antiviral ST-246 as a smallpox therapeutic.

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Grosenbach DW, Jordan R, Hruby DE

Development of the small-molecule antiviral ST-246 as a smallpox therapeutic.

Future Virol. 2011 May;6(5):653-671. doi: 10.2217/fvl.11.27.

PubMed ID
21837250 [ View in PubMed
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Abstract

Naturally occurring smallpox has been eradicated, yet it remains as one of the highest priority pathogens due to its potential as a biological weapon. The majority of the US population would be vulnerable in a smallpox outbreak. SIGA Technologies, Inc. has responded to the call of the US government to develop and supply to the Strategic National Stockpile a smallpox antiviral to be deployed in the event of a smallpox outbreak. ST-246((R)) (tecovirimat) was initially identified via a high-throughput screen in 2002, and in the ensuing years, our drug-development activities have spanned in vitro analysis, preclinical safety, pharmacokinetics and efficacy testing (all according to the 'animal rule'). Additionally, SIGA has conducted Phase I and II clinical trials to evaluate the safety, tolerability and pharmacokinetics of ST-246, bringing us to our current late stage of clinical development. This article reviews the need for a smallpox therapeutic and our experience in developing ST-246, and provides perspective on the role of a smallpox antiviral during a smallpox public health emergency.

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