SIGA Technologies completes enrollment of Phase 1 clinical study for new smallpox treatment

SIGA Technologies, Inc. recently completed its enrollment and dosing of healthy individuals in a Phase 1 clinical study of TPOXX, an intravenous formulation intended for the treatment of smallpox and related orthopoxvirus infections.

SIGA said the treatment is intended for patients who cannot take oral smallpox medication.

“We are very pleased to have completed dosing in this important safety study for the IV formulation of TPOXX,” SIGA Chief Executive Officer Phil Gomez said. “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.”

Treatments were administered at four sequentially increasing doses, beginning with the lowest dose for safety purposes. Higher doses were selected based on predicted exposures that would be safe and comparable to exposure levels received after similar oral doses at 600mg twice daily. SIGA said its predictions were based on efficacy studies in animal models.

TPOXX was developed under the U.S. Food and Drug Administration’s (FDA) Animal Rule. The rule states that drugs used to prevent life-threatening conditions caused by toxic substances may be granted marketing approval by the FDA based on the results of well-controlled animal efficacy studies when the results of those studies can be reasonably likely to produce clinical benefit in humans.

Funding for the study was provided by the Biomedical Advanced Research and Development Authority (BARDA).