SIGA Technologies, Inc. today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID).
This CRADA will focus on Good Laboratory Practice (GLP) studies of TPOXX® for post-exposure prophylaxis (PEP) using a U.S. Food and Drug Administration (FDA)-approved non-human primate model of TPOXX efficacy against smallpox infection.
PEP regimens are designed to prevent infection in individuals who have known or potential exposure to an infectious agent but are not symptomatic. Such regimens have been used successfully to reduce the impact of other infections.
The FDA has already approved the oral formulation TPOXX for the treatment of smallpox, and its use in the PEP setting could provide significant potential benefit in the event of an outbreak.
While vaccines would play an important role in containing the spread of smallpox, they are only effective if administered prior to infection or no later than four days after infection. However, symptoms of smallpox do not typically appear until approximately 14 days post-infection, and there is currently no diagnostic test to determine infection prior to symptom onset.
Given the uncertainty of an individual’s infection status in that two-week period, the administration of vaccine in combination with TPOXX could potentially be an important strategy for reducing morbidity and mortality in a smallpox outbreak.
The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox on July 13, 2018. In September 2018, SIGA signed a new contract with Biomedical Advanced Research and Development Authority (BARDA) for additional procurement and development related to both oral and intravenous formulations of TPOXX.
