SIGA Technologies Announces DOD Increases Funding to Develop Post-Exposure Prophylactic Indication for TPOXX®
SIGA Technologies, Inc. (SIGA) today announced that the United States Department of Defense (DoD), via the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), has increased research and development funding to approximately $23 million in connection with the DoD contract to support work necessary to gain a potential label expansion from the U.S. Food and Drug Administration (FDA) for TPOXX® (tecovirimat) for Post-Exposure Prophylaxis (PEP) in addition to the current approved labeling for the treatment of smallpox.
The use of TPOXX for PEP could provide significant potential benefit in the event of a smallpox pandemic or 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, and the highly contagious nature of smallpox, the administration of a vaccine in combination with TPOXX could be an important strategy for reducing morbidity and mortality in a smallpox outbreak. Dosing of TPOXX in the PEP indication is expected to be 28 days rather than the 14-day dosing currently recommended for its use in treating patients with active smallpox infections. This would increase the amount of TPOXX used for each exposed person compared with each infected person.
“During our FDA Advisory Committee meeting in May 2018, several committee members emphasized the importance of evaluating the potential use of TPOXX not only to treat smallpox symptomatic infection, but also to treat patients with known smallpox exposure who have not yet developed symptoms,” said Dr. Phil Gomez, CEO of SIGA. “An expansion of the TPOXX label to include its use for PEP would provide greater flexibility to deliver TPOXX to those who might benefit from treatment during a potential outbreak. The recent search for prophylactic agents that could be used for PEP in patients with known exposure to the virus that causes COVID-19 underscores the importance of being able to prevent infection in at-risk individuals. We are pleased to be working with DoD on important studies for a PEP indication that could address similar situations that would arise in the event of a smallpox outbreak.”