Therapy Areas: Respiratory
Direct awarded US FDA approval to commence a Phase I/II trial of ExoFlo for post-acute COVID-19 syndrome
21 July 2021 -

Biologic products supplier Direct Biologics reported on Tuesday the receipt of approval from the US FDA to commence a Phase I/II trial under an Investigational New Drug (IND) protocol for ExoFlo for the treatment of Post-Acute COVID-19 Syndrome later in 2021.

ExoFlo is the company's second approved IND and the first IND ever approved by US FDA for the use of extracellular vesicles (EVs) to treat Post-Acute COVID-19 syndrome, Chronic Post-COVID-19 syndrome, or any post-viral syndrome. ExoFlo is an investigational allograft extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). It provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.

The double-blind, placebo-controlled, randomized clinical trial will evaluate the therapeutic effect of ExoFlo infusion upon the debilitating set of symptoms, most commonly fatigue and shortness of breath, that severely limit quality of life for a large proportion of patients for weeks and months after the acute COVID-19 infection has subsided. The infusions will be administered in an outpatient setting.

This Phase I/II EIPACS IND approval reportedly follows the successful completion of two clinical trials evaluating ExoFlo for the treatment of COVID-19 related acute respiratory distress syndrome (ARDS) in inpatient and ICU settings. The trials serve as a prelude to the next stage of the company's ongoing effort in the fight against the COVID-19 pandemic.