Aegle Therapeutics Corp., a clinical-stage biotechnology company developing novel extracellular vesicle (“EV”) therapies to address rare and serious diseases, today announced the first patient has been dosed in the Phase 1/2a clinical trial of AGLE-102™ for the treatment of severe second-degree burns. AGLE-102 is an investigational product comprised of native extracellular vesicles isolated from allogeneic stem cells using Aegle’s proprietary and patented methods. The product is a composite of cell-derived nanoparticles that contain active biomolecules including proteins and nucleic acids with tissue regeneration, immunomodulation, and anti-inflammation properties.
The phase I/2a trial, “A Pilot Safety Study of Mesenchymal Stem Cell Derived Extracellular Vesicles for the Treatment of Burn Wounds,” is a prospective, non-randomized, single arm multi-center study designed to evaluate the safety and efficacy of applying multiple administrations of AGLE-102 to deep second-degree burns. The program is being advanced for the discovery and development of allogeneic stem cell derived extracellular vesicle therapy that could offer patients accelerated healing, regenerative healing (with minimal/no scarring) and prevention of wound conversion. More information on the phase 1/2a study (NCT05078385) is available at clinicaltrials.gov.
“We are pleased to initiate this first-in-human trial of AGLE-102,” said Shelley Hartman, Aegle’s Chief Executive Officer. “This milestone highlights our commitment to advancing extracellular therapy as an important multi-faceted approach to treating severe dermatological and immune based conditions.”
AGLE-102 is an investigational product comprised of native extracellular vesicles isolated from allogeneic stem cells. The product is a composite of cell-derived nanoparticles that contain active biomolecules including proteins and nucleic acids with tissue regeneration, immunomodulation, and anti-inflammation properties. Aegle is currently enrolling patients in a phase 1/2a study using AGLE-102 to prevent wound progression and scarring in severe second-degree burns and anticipates the launch of a phase 1/2a study in Q4 2023 for the treatment of epidermolysis bullosa. AGLE-102 is also in a preclinical program for GvHD.