Post-Exposure Prophylaxis (PEP)
Post-exposure prophylaxis (PEP) regimens are designed to block or reduce impact of infections in individuals who have known or potential exposure to an infectious agent but are not symptomatic. Such regimens have been used successfully for other infections. In October 2018, SIGA entered into a Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) with a focus on Good Laboratory Practice (GLP) studies of TPOXX® for PEP using a U.S. Food and Drug Administration (FDA)-approved non-human primate model of TPOXX® efficacy against smallpox infection. In July 2019, SIGA was awarded a multi-year contract from the United States Department of Defense (DoD) to support work necessary to gain a potential label expansion for TPOXX® that would include PEP of smallpox.
This contract is valued at $26.2 million and will support the clinical studies and regulatory submission activities required to evaluate the use of TPOXX for PEP.