Direct Biologics LLC, a manufacturer of regenerative medical products, reported on Tuesday the receipt of US FDA expanded access for ExoFlo to treat patients with COVID-19 associated acute respiratory distress syndrome (ARDS) under its national multi-centre, Phase II, placebo controlled, randomized clinical trial (EXIT COVID-19).

Under the expanded access protocol, the company said it will make ExoFlo available to a broader group of patients with severe COVID-19, many of whom would not meet acceptance criteria for EXIT COVID-19, often under conditions of "compassionate use."

ExoFlo is an investigational new drug that has not been approved or licensed by FDA. It is an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides natural bioactive signals that have been shown to modulate inflammation and direct cellular communication, added the company.

This US FDA expanded approval protocol follows multiple approvals for single patient Emergency Investigational New Drug (eIND) applications granted in September and October. The emergency INDs are a mechanism by which physicians can obtain rapid approval to administer medication to a single patient through a direct appeal to the FDA, Direct Biologics concluded.