In July 2018, the US Food and Drug Administration (FDA) approved the first treatment for the smallpox virus created by SIGA Therapeutics, which then agreed to supply two million doses to the US Strategic National Stockpile.
Last week, BioFactura announced that it had also been awarded a contract to advance its antibody-based countermeasure to the variola virus.
The agreement sees the US Biomedical Advanced Research and Development Authority (BARDA) provide up to $67.4m (€61.7m) to create a second anti-viral therapeutic with a different mechanism of action to SIGA’s treatment.
The funds will be used to develop the manufacturing processes for the drug components, final product formulation, and the company’s engagement with the FDA.
Further than this, the contract allows for additional payments to be released to support clinical manufacture and to support moving the drug into human trials.
Darryl Sampey, CEO of BioFactura, stated, “This advanced research and development contract award marks the culmination of decades of discovery and development work performed by our team, our partners at the National Institutes of Health and our principal government collaborator, Jay Hooper, at the US Army Research Institute of Infectious Diseases.”
Though smallpox has been considered eradicated since 1980 by the WHO, there are still samples of the virus held in laboratories globally. The development of a ‘biodefense therapeutic’ allows the US to address any spread of the virus through bioterrorism or via inadvertent release.
In addition to treatments, the FDA also recently approved a further smallpox vaccine and monkeypox vaccine, becoming the first vaccine given marketing authorization for the latter indication.