SIGA Technologies, Inc. (SIGA) (OTCMKTS:SIGA), a company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, today announced the completion of enrollment and dosing in the final cohort of healthy subjects in a Phase I clinical study of an intravenous (IV) formulation of its lead drug candidate, TPOXX® (tecovirimat). TPOXX is being developed for the treatment of smallpox, as well as other orthopoxvirus infections. There were no drug-related Serious Adverse Events (“SAEs”) reported.
The IV formulation of TPOXX provides an important additional tool in smallpox preparedness for use in populations who cannot take an oral formulation. This first in human single ascending dose IV study was conducted at four sequentially increasing doses. The study initiated at the lowest dose to evaluate the drug for safety. The higher doses studied were selected based on predicted exposures that would be safe and would provide exposure levels in humans comparable to the exposure levels after oral dosing at 600mg twice daily, which is the dose predicted for efficacy based on animal models. The IV study demonstrated a linear response that the Company expects will allow it to determine the appropriate dose for the IV formulation and simplifies clinical development of the product.
TPOXX (tecovirimat) is being developed under the U.S. Food & Drug Administration’s “Animal Rule,” in which efficacy endpoints are determined in animal studies, and human clinical studies are conducted to determine safety and confirm dosing. This Phase I study is wholly funded by the U.S.government’s Biomedical Advanced Research and Development Authority (BARDA).
“We are very pleased to have completed dosing in this important safety study for the IV formulation of TPOXX. The Phase I safety data demonstrating the absence of drug-related Serious Adverse Events are consistent with previous data from studies of our oral formulation. These results position TPOXX for further successful development and potential procurement of the IV formulation in partnership with BARDA,” said Dr. Phil Gomez, Chief Executive Officer of SIGA Technologies, Inc.
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats. The company’s lead product is Tecovirimat, TPOXX®, also known as ST-246®, an orally administered and IV formulation 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 www.siga.com.
Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. No cure or treatment for smallpox exists. A vaccine can prevent smallpox, but the risk of the vaccine’s side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.