NEW YORK --(BUSINESS WIRE)-- SIGA Technologies, Inc a company specializing in the development of pharmaceutical agents to combat bio-warfare pathogens, announced today that it has begun enrolling the second and final cohort of healthy subjects for the Phase III clinical study for its lead drug candidate, TPOXX (tecovirimat), for the treatment of orthopoxvirus. This Phase III study, which is wholly funded the by the Biomedical Advanced Research and Development Authority (BARDA) will be conducted at eleven approved investigative sites with a total of approximately 360 subjects.
The initial Phase III lead cohort of 40 subjects in this trial has already completed participation without any reports of serious adverse events.
Screening of subjects for the second Phase III cohort initiated on April 11, 2016 , and the first subject was enrolled and dosed on April 18, 2016 . Since tecovirimat is being developed under the FDA "Animal Rule," there are no efficacy endpoints in this clinical trial. This study will generate safety and pharmacokinetic data in support of the prescribing information that will be part of the New Drug Application (NDA) filing.