Aegle Therapeutics Corp. Announces First Patient Dosed in Phase 1/2a Clinical Trial Administering a Novel Extracellular Vesicle Therapy

Phase 1/2a clinical trial will evaluate the safety and efficacy of administering AGLE-102™ to treat severe second-degree burns

AGLE-102™ is being developed for the treatment of severe dermatological and immune based disorders

WOBURN, Mass., Aug. 16, 2023 /PRNewswire/ -- 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.”

About AGLE-102™
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.

About Aegle Therapeutics Corp.
Aegle Therapeutics Corp. is a clinical-stage biotechnology company developing novel extracellular vesicle (“EV”) therapies to address rare and serious diseases and disorders with significant unmet medical needs. Aegle’s proprietary platform technology safely isolates native extracellular vesicles (“EVs”) from stem cells. These EVs carry complex assemblies of biologic molecules such as proteins and nucleic acids that can induce a wide variety of effects in recipient cells, including the promotion of regenerative healing, while reducing inflammation and modulating the immune system. Aegle’s EV therapy has the potential to treat a broad range of indications in multiple therapeutic areas, including dermatology, immunology-based diseases, protein deficient disorders and others. For more information about Aegle Therapeutics, please visit www.aegletherapeutics.com.

Aegle Therapeutics Investor Contact:
Investor Relations
info@aegletherapeutics.com

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SOURCE Aegle Therapeutics Corporation