Aegle Therapeutics Corporation is the first extracellular vesicle (EV) company to be cleared by the FDA to enter clinical trials in humans. Headquartered in Miami, FL, the company is using allogeneic bone marrow mesenchymal stem cell (BM-MSC) derived extracellular vesicles to treat severe dermatological disorders, with a focus on burn treatments.
In May 2018, Aegle announced that the FDA cleared its first Investigational New Drug (IND) application to initiate a clinical trial in severe second degree burn patients. The company plans to launch a Phase 1/2a clinical trial of its lead product AGLE-102 in late 2018.
The open label dose escalation study will enroll patients at several sites in the U.S., evaluating the safety of extracellular vesicle therapy in burn patients. [Read more…]