Siga Technologies Inc., a company that focuses on the creation and sale of solutions for biodefense and medical needs with unmet problems, recently launched its phase-one single ascending dose clinical study for TPOXX in an intravenous (IV) formulation.
TPOXX is the top drug candidate at the company. It is designed to treat orthopoxvirus diseases. To conduct the study, Siga collaborated with the Biomedical Research and Development Authority (BARDA).
The purpose of the study is to determine the safety and pharmacokinetic value of developing a protocol for the company’s next phase-one clinical trial within its IV program. The next phase is a multiple ascending dose safety as well as pharmacokinetic trial.
“This collaboration with BARDA on an IV formulation is an important step toward realizing the full capability of TPOXX,” Siga CEO Eric Rose said. “This trial advances our efforts to ensure better protection of Americans from a smallpox outbreak.”
Siga’s ultimate goal within its IV program is to develop formulations of IVs that can be used as alternative treatments for people who have dysphagia. It will also be useful for patients who are seriously sick, hospitalized or cannot swallow the traditional oral capsules.