SIGA initiates Phase I tecovirimat intravenous formulation study

SIGA Technologies, Inc., announced on Thursday that it has the initiated a Phase I single ascending dose clinical study for the intravenous (IV) formulation of its lead drug candidate TPOXX (tecovirimat) for the treatment of orthopoxvirus diseases.

Orthopoxvirus diseases include smallpox and the vaccinia, monkeypox and cowpox viruses.

Screening for the tecovirimat study began on March 7, and the company plans to have the first subject is expected to be enrolled and dosed on or about March 21.

The study is being funded the by the Biomedical Advanced Research and Development Authority (BARDA), which will evaluate the safety data from the study as well as pharmacokinetic data to aid in the development of a protocol for the next Phase I clinical trial in the IV program, which is a multiple ascending dose safety and pharmacokinetic trial.

“This collaboration with BARDA on an IV formulation is an important step toward realizing the full capability of TPOXX,” Dr. Eric Rose, SIGA’s CEO, said. “This trial advances our efforts to ensure better protection of Americans from a smallpox outbreak.”

Siga is developing the IV formulation of tecovirmat as an alternative treatment for individuals who suffer from dysphagia or seriously ill individuals who are hospitalized and cannot swallow oral capsules.