Aegle Therapeutics is developing a novel therapy using extracellular vesicles isolated from mesenchymal stem cells to deliver therapeutically significant RNA, proteins and immunomodulatory agents to diseased and damaged cells in the body.
Our first indication is dystrophic epidermolysis bullosa (“DEB”), a rare, pediatric connective tissue disorder. DEB is monogenetic and caused by the body’s inability to make enough, or in severe cases any, type VII collagen (“COL7”). The result is severe skin blistering resulting in chronic and recurring wounds, disfigurement, and extraordinary pain. Aegle’s EV product, AGLE-102TM, provides a unique, multifaceted approach to DEB. AGLE-102 contains COL7 protein as well as COL7A1 mRNA, which in preclinical models stimulates recessive DEB cells (those that cannot make any COL7) to produce COL7. In addition, AGLE-102 carries the non-immunogenic, immunomodulating and anti-inflammatory agents of their MSC parents. Aegle believes AGLE-102 has the potential for functional regeneration and organization of complex tissue structures in DEB patients that can accelerate and enhance healing, reduce scarring, and improve overall cosmesis. Aegle’s IND for DEB has been cleared by the FDA and the Aegle expects to enter the clinic mid-2023.
In addition to DEB, Aegle plans to initiate a clinical trial in early 2023 to treat burn patients using AGLE-102. This trial is funded by a grant from the Department of Defense and will evaluate accelerated healing, scarring, hair growth, re-pigmentation and wound progression in severe second degree burn patients. Aegle’s IND for severe second-degree burns has been cleared by the FDA.
Aegle’s technology, exclusively licensed from the University of Miami, has a broad range of potential indications in dermatology, immuno-oncology, and Aegle’s Platforms. Aegle’s base patent covering method and use has been granted in all major markets worldwide. Aegle has filed additional patents that cover composition of matter and the use of Aegle’s EVs in epidermolysis bullosa, graft vs. host and IBD, and Aegle’s Platform indications.