SIGA Technologies, Inc., received approval on Tuesday from its data safety monitoring board (DSMB) to complete enrollment in the second and final cohort of healthy subjects for the Phase III clinical study of TPOXX for the treatment of orthopoxvirus infections.
The approval was based on a study of safety data from the first 125 participants in the final cohort. Eleven approved clinical investigation sites will conduct the Phase III review, with a total of 380 individuals participating. The initial Phase III cohort of 40 subjects in the trial was completed in 2015 with zero reports of serious adverse side effects.
The Phase III study is wholly funded by the Biomedical Advanced Research and Development Authority (BARDA).
SIGA also submitted its final pivotal animal study reports to the U.S. Food and Drug Administration (FDA). The DSMB decision, along with the FDA submission, entitles SIGA to a milestone payment from BARDA of $20.5 million.
SIGA said that it anticipates submitting the complete new drug application for TPOXX by the end of 2017.
SIGA Technologies specializes in the development and commercialization of solutions for serious unmet medical needs and biothreats. The company has working relationships with the National Institutes of Health, BARDA, the Centers for Disease and Control, and the U.S. Department of Defense.