Aegle Therapeutics Begins Dosing in AGLE-102 Trial for DEB

Aegle Therapeutics Corp., a clinical-stage biopharmaceutical firm, recently announced the commencement of a Phase 1/2a clinical trial evaluating AGLE-102 for treating Dystrophic Epidermolysis Bullosa (DEB), a rare pediatric skin blistering disease. The trial marks a significant milestone in the development of this novel extracellular vesicle (EV) therapy.

AGLE-102 is an investigational therapy designed using extracellular vesicles derived from allogeneic stem cells through Aegle’s proprietary methods. These vesicles are essentially cell-derived nanoparticles packed with active biomolecules, including proteins and nucleic acids, that possess anti-inflammatory, immunomodulating, and tissue regenerating properties.

“We are thrilled to announce the initiation of this Phase 1/2a clinical trial for DEB, a complex disease characterized by chronic blistering and excessive inflammation. Aegle is committed to advancing new therapies to address the continued unmet medical need of this patient population,” said Shelley Hartman, Aegle’s Chief Executive Officer.

Evangelos Badiavas, MD, PhD, Co-Founder and Chief Scientific Officer of Aegle, elaborated on the mechanism of AGLE-102. He noted that the therapy is designed to emulate the body's natural healing processes. It delivers essential proteins, such as collagen 7, along with other critical biomolecules like nucleic acids, which collectively work to reduce inflammation, modulate the immune system, and stimulate diseased cells to produce their own collagen 7. This multi-faceted approach offers a unique treatment methodology for DEB.

The Phase 1/2a trial, entitled “A Safety Study of the Administration of Mesenchymal Stem Cell Extracellular Vesicles in the Treatment of Dystrophic Epidermolysis Bullosa Wounds,” is a prospective, non-randomized, multi-center study aimed at assessing the safety and efficacy of multiple doses of AGLE-102 in treating chronic lesions. Detailed information about this study can be found under identifier NCT04173650 at clinicaltrials.gov.

AGLE-102 is a complex composition of nanoparticles known as extracellular vesicles, which are secreted by allogeneic mesenchymal stem cells. These vesicles are intricate assemblies of active biomolecules capable of inducing a variety of effects in recipient cells. AGLE-102 is currently being assessed in two Phase 1/2a studies for DEB and severe burns. Previous clinical trials have reported promising results in the treatment of burns. Additionally, AGLE-102 is undergoing preclinical evaluation for the treatment of Graft versus Host Disease (GvHD).

Aegle Therapeutics Corp. is dedicated to developing innovative extracellular vesicle therapies aimed at treating immune and inflammatory-based dermatological disorders. The company continues to strive towards addressing the unmet medical needs of patients suffering from these complex conditions.

In summary, the initiation of the Phase 1/2a clinical trial for AGLE-102 marks a noteworthy advancement in the treatment of DEB. With its unique approach to emulating the body's healing mechanisms, Aegle Therapeutics aims to bring new hope to patients suffering from this debilitating condition.