Aegle Therapeutics Corp., a clinical-stage biotechnology company, has announced the initiation of its Phase 1/2a clinical trial, marking the dosing of its first patient. The trial will focus on the administration of AGLE-102™, a novel therapy designed to treat severe second-degree burns.
AGLE-102™ is an investigational product made up of native extracellular vesicles, which are derived from allogeneic stem cells using Aegle’s unique and patented methods.
This product is a combination of cell-derived nanoparticles that carry active biomolecules, including proteins and nucleic acids. These biomolecules possess properties related to tissue regeneration, immunomodulation, and anti-inflammation.
The Phase 1/2a trial, titled “A Pilot Safety Study of Mesenchymal Stem Cell Derived Extracellular Vesicles for the Treatment of Burn Wounds,” is a forward-looking, non-randomized, single-arm multi-center study. Its primary objective is to evaluate the safety and efficacy of AGLE-102™ when applied to deep second-degree burns.
The overarching goal of the program is to explore and develop a therapy derived from allogeneic stem cell extracellular vesicles. This therapy aims to provide patients with accelerated healing, regenerative healing with minimal or no scarring, and prevention of wound conversion. Further details about the study can be found on clinicaltrials.gov under the identifier NCT05078385.
Shelley Hartman, Aegle’s Chief Executive Officer, expressed her enthusiasm about the trial, emphasizing the company’s dedication to advancing extracellular therapy. This approach is seen as a multifaceted solution to treating severe dermatological and immune-based conditions.
About AGLE-102™: AGLE-102™ is an investigational product that consists of native extracellular vesicles sourced from allogeneic stem cells. It is a composite of cell-derived nanoparticles that contain active biomolecules, which have properties related to tissue regeneration, immunomodulation, and anti-inflammation.
Aegle is currently enrolling patients for a phase 1/2a study that uses AGLE-102™ to prevent wound progression and scarring in severe second-degree burns. Additionally, a phase 1/2a study is anticipated to launch in Q4 2023 for the treatment of epidermolysis bullosa. AGLE-102™ is also part of a preclinical program for GvHD.
About Aegle Therapeutics Corp.: Aegle Therapeutics Corp. is a clinical-stage biotech company that is pioneering the development of novel extracellular vesicle (“EV”) therapies.
These therapies are designed to address rare and severe diseases and conditions that currently have significant unmet medical needs. Aegle’s proprietary technology isolates native extracellular vesicles from stem cells.
These EVs carry complex biological molecules, such as proteins and nucleic acids, that can induce a variety of effects in recipient cells. This includes promoting regenerative healing, reducing inflammation, and modulating the immune system.
Aegle’s EV therapy has the potential to treat a broad spectrum of indications across multiple therapeutic areas, including dermatology, immunology-based diseases, protein-deficient disorders, and more. For additional information about Aegle Therapeutics, you can visit their official website at www.aegletherapeutics.com.