Aegle Therapeutics is Awarded IND to Test Extracellular Vesicles from Stem Cells in Burn Patients

Aegle Therapeutics is a Miami, FL-based biotechnology company that has taken a completely novel approach to regenerative medicine.  Aegle Therapeutics has developed new techniques to isolated extracellular vesicles made by cultured stem cells.  Specifically, Aegle Therapeutics isolate extracellular vesicles from bone marrow-based mesenchymal stem cells for therapeutic purposes.

Scientists at Aegle Therapeutics have shown that standard protocols used to isolated extracellular vesicles tend to badly damage them.  If these damaged extracellular vesicles are administered to injured animals, they tend to induce inflammation and fail to promote healing.  Aegle has demonstrated this very fact by administering extracellular vesicles (EVs) isolated by standard protocols to pigs suffering from skin injuries.  These damaged EVs did not promote healing and made the injuries worse.  However, if similarly, injured pigs were administered undamaged, whole EVs isolated with Aegle Therapeutics’ proprietary protocols, they not only accelerated healing, but they significantly decreased scarring and promoted the formation of blood vessels and hair follicles and nerve regeneration.

Aegle’s isolation process is also easily scalable and low-cost.

Aegle Therapeutics has used their whole EV preparations to treat severe dermatological disorders, with a specific focus on the treatment of burns. In May 2018, Aegle announced that the US Food and Drug Administration (FDA) approved an Investigational New Drug (IND) application. This IND will examine the use of whole EVs from mesenchymal stem cells to treat severe second degree burn patients. This is an open label dose escalation study, which means that the patients and their physicians will know that they are being treated with the experimental product, but randomly-assigned groups of patients will receive gradually increasing doses of the EVs. This clinical trial will test both safety and efficacy (a Phase 1/2a clinical trial) of Aegle Therapeutics’ lead product, AGLE-102. This clinical trial will enroll burn patients at several U.S. sites.

According to the founder and Chief Science Officer of Aegle Therapeutics, Evangelos Badiavas, M.D., Ph.D., “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 Shelly Hartman, Chief Executive Officer 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 is also developing another product, AGLE-103 for the treatment of a genetic skin condition called epidermolysis bullosa (EB), which causes the skin to be fragile and blister.