MIAMI (PRWEB) May 20, 2019
Aegle Therapeutics Corporation, an extracellular vesicle (“EV”) therapy company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to begin clinical trials in dystrophic epidermolysis bullosa (“DEB”) patients. DEB is a rare pediatric skin blistering disease that affects approximately 500,000 patients worldwide. Aegle expects to initiate a Phase 1/2 clinical trial of AGLE-103 for the treatment of DEB in late 2019.
“We are excited to be developing a multifaceted approach to DEB. In addition to carrying the regenerative wound healing messages of mesenchymal stem cells, Aegle’s EVs also deliver COL7 and COL7A1 mRNA to diseased cells, inducing recessive DEB cells to produce their own COL7 protein. We believe this product has the potential to address patients’ COL7 deficiency as well as accelerate wound healing,” said Evangelos Badiavas, M.D., PhD, Aegle’s Founder and Chief Scientific Officer. "Currently, patients with DEB suffer severe blistering, acute and chronic wounds, scarring, loss of mobility and chronic pain. There is still no treatment or cure for EB.”
Aegle’s proprietary and innovative EV therapy involves the isolation of extracellular vesicles released by allogeneic bone marrow derived mesenchymal stem cells using a proprietary process. "We are excited to be the first company to advance extracellular vesicle therapy into the clinic. Our primary focus is moving AGL-103 into patients,” said Shelley Hartman, Chief Executive Officer of Aegle. “We are only at the brink of understanding the potential of extracellular vesicles and we are excited to be pioneers in EV therapy.”
The Phase 1/2 study will evaluate the safety of extracellular vesicle therapy in dystrophic epidermolysis bullosa patients. The study is an open label dose escalation protocol that will enroll patients at several sites in the United States.
About Aegle Therapeutics Corp.
Aegle Therapeutics is a clinical stage extracellular vesicle therapy company developing novel therapeutics based on its proprietary extracellular vesicle isolation technology. The company is isolating extracellular vesicles released by allogeneic bone marrow derived mesenchymal stem cells for the treatment of severe dermatological conditions. Aegle’s EV therapy is initially being developed to dystrophic epidermolysis bullosa, a rare pediatric connective tissue disease.
For more information, visit http://www.aegletherapeutics.com.