Siga announces start of tpoxx® post-exposure prophylactic (“pep”) clinical trials

New york, march 02, 2022 (globe newswire) -- siga technologies, inc. (siga) (nasdaq: siga), a commercial-stage pharmaceutical company focused on the health security market, today announced that it has initiated the clinical program to support a u.s. food and drug administration (fda) label expansion for post-exposure prophylaxis (“pep”) for oral tpoxx®, approved in july 2018 for the treatment of smallpox. the first study is a comparison of the enrolled participants' immune response with the jynneos smallpox vaccines compared with the immune response with jynneos while on tpoxx treatment. the study is designed to determine if tpoxx interferes with the development of an effective immune response to the vaccine. a second clinical study, also expected to commence in 2022, will look at developing an expanded safety dataset to support 28 day dosing of tpoxx for the post-exposure prophylaxis indication compared with the currently approved 14 days for treatment of smallpox indication.
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