NEW YORK – August 29, 2016 – SIGA Technologies, Inc. (SIGA) (OTCMKTS:SIGA), a company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, announced completion of enrollment and dosing in 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 infections. There were no drug-related Serious Adverse Events reported through 14 days of dosing, and 14 days of additional follow up. This final cohort of the Phase III pivotal safety study was conducted at eleven approved clinical investigation sites in a total of approximately 380 subjects.
The initial Phase III cohort of 40 subjects in this trial was completed in 2015 without any reports of Serious Adverse Events. Since TPOXX™ (tecovirimat) is being developed under the FDA “Animal Rule,” there are only safety and not efficacy endpoints in this clinical trial. This Phase III study is wholly funded by the Biomedical Advanced Research and Development Authority (BARDA).
“We are very pleased to have completed dosing in this important safety study for TPOXX. The Phase III safety data without any drug-related Serious Adverse Events is consistent with our animal studies, and positions the product well for review and approval by the FDA,” said Dr. Eric Rose, Chief Executive Officer of SIGA Technologies, Inc.
SIGA anticipates submitting the complete New Drug Application (NDA) for TPOXX™ to the FDA by the end of 2017 and will seek an expedited review of its submission.
About SIGA Technologies, Inc. and TPOXX™
We are a company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats. Our lead product is Tecovirimat, TPOXX™, also known as ST-246®, an orally administered antiviral drug that targets orthopoxvirus infections. While TPOXX™ is not yet approved as safe and effective by the U.S. Food & Drug Administration, it is a novel small-molecule drug that is being delivered to the Strategic National Stockpile under Project BioShield. For more information about SIGA, please visit SIGA’s web site at www.siga.com.