ST-246 is being developed as a countermeasure to prevent the spread of variola virus, the causative agent of smallpox, which while no longer present in the environment is thought to be a formidable biowarfare threat.
Three registrational batches of the compound were produced on Siga’s behalf by Louisiana-headquartered Albemarle at its good manufacturing practice (GMP) accredited facility in South Haven, Michigan. Siga will use the stocks to produce 1m drug capsules to support subsequent trials and future regulatory filings.
Siga’ CEO Eric Rose said the production of trial batches was a significant step in ST-246’s development because it shows the firm “can commercialise this anti-viral through large-scale manufacturing”.
In 2006, Siga won a $16.5m (€11.3m) contract to develop ST-246 for military applications under the US government’s multi-agency bio-defense preparedness strategy and stockpiling programme.
Earlier this year the scope of the ST-246 project was broadened to develop parenteral formulations designed for use by the civilian population under a $55m grant from the National Institute of Allergy and Infectious Diseases (NIAID).
Two weeks ago Siga announced the completion of a Phase I investigational trial to evaluate the pharmacokinetics of various forms of ST-246. Initial data indicate that both versions provide similar levels exposure to the drug.
Risk of bio-terrorism?
Earlier this month the Commission on the Prevention of Weapons of Mass Destruction and Terrorism recommended that incoming president Barrak Obama make bio-terrorism a top priority.
The commission concluded that while a nuclear attack would cause more deaths, biological weapons like smallpox and anthrax can be more easily obtained, handled and could be as damaging to the US in terms of the level of panic they create.