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.
Aegle Therapeutic’s Phase 1/2a Clinical Trial
According to Evangelos Badiavas, M.D., PhD, Aegle’s Founder and CSO, “We are excited to be moving our EV therapy into the clinic to treat burns, an indication with a substantial unmet medical need. We believe this product has the potential for functional regeneration and organization of complex tissue structures that can enhance healing, reduce scarring, minimize contraction and improve overall cosmesis. Currently, patients with burns suffer scarring, disfigurement, loss of mobility and chronic pain. There’s a real need for better therapies.”
According to Shelley Hartman, CEO of Aegle, “This achievement is an important step as the company launches a Series A capital raise in 2018 to fund its clinical development.”
Aegle Therapeutics Corporation
Aegle Therapeutics is a clinical-stage regenerative medicine company that is developing cell-free therapeutics. Its technology platform utilize a proprietary extracellular vesicle (EV) isolation technology that is “easy to scale, low cost and produces EVs with an extended shelf life.”
The company is developing two products, AGLE-102 for the treatment of burns and scarring and AGLE-103 for the treatment of epidermolysis bullosa (EB). EB is a a genetic condition that causes the skin to be fragile and blister.
Aegle Therapeutics’ announcement about receiving FDA clearance for its IND involving the use of a MSC-derived extracellular vesicle therapy for burn victims is available here.
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