ExoFlo is an acellular human bone marrow mesenchymal stem cell (MSC) obtained EV product developed leveraging Direct Biologics’ EV platform technology
FDA Building 51 houses the Center for Drug Evaluation and Research. (Credit: The U.S. Food and Drug Administration/Wikipedia)
Direct Biologics has secured Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its extracellular vesicle (EV) drug product, ExoFlo, to treat Covid-19-linked acute respiratory distress syndrome (ARDS).
ExoFlo is an acellular human bone marrow mesenchymal stem cell (MSC) obtained EV product developed leveraging Direct Biologics’ EV platform technology.
It includes signalling molecules from bone marrow MSCs and uses the anti-inflammatory and regenerative characteristics of these MSCs without the cost, complexity and scale limitations related to stem cell transplantation.
The RMAT designation is intended to fast-track the approval of potential regenerative medical products in the US that show clinical signs to meet an unmet medical need for a serious life-threatening disease.
Through early and regular discussions, the US FDA offers detailed guidance on therapy development and post-market needs under the RMAT designation.
Additionally, RMAT provides eligibility for accelerated approval and priority review of biologics licensing applications.
Direct Biologics CEO Mark Adams said: “After intensively reviewing our preclinical data, manufacturing processes, and clinical data from our Phase II multicentre, double-blinded, placebo-controlled randomised clinical trial, the FDA has recognised ExoFlo as a lifesaving treatment for patients suffering from acute respiratory distress syndrome (ARDS) due to severe or critical Covid-19.
“The additional attention, resources, and regulatory benefits provided by an RMAT designation demonstrate that the FDA views ExoFlo as a product that can significantly enhance the standard of care for the thousands still dying from ARDS every week in the US.”