Pharma Focus America

Aegle Therapeutics Corp. Initiates Phase 1/2a Clinical Trial, Administering Novel Extracellular Vesicle Therapy to First Patient

Thursday, August 17, 2023

Aegle Therapeutics Corp, a clinical-stage biotech firm dedicated to developing innovative extracellular vesicle ("EV") therapies for addressing rare and severe diseases, has announced the initiation of Phase 1/2a clinical trials for AGLE-102™. This experimental therapy aims to treat severe second-degree burns using extracellular vesicles extracted from allogeneic stem cells, employing Aegle's proprietary methods. These vesicles comprise cellular nanoparticles containing active biomolecules such as proteins and nucleic acids known for their potential in tissue regeneration, immune modulation, and anti-inflammatory effects.

The clinical trial, named "A Pilot Safety Study of Mesenchymal Stem Cell Derived Extracellular Vesicles for the Treatment of Burn Wounds," is designed as a prospective, non-randomized, single-arm, multi-center study. Its primary objective is to assess the safety and effectiveness of administering multiple doses of AGLE-102 to deep second-degree burns. The program aspires to introduce an innovative therapy derived from extracellular vesicles of allogeneic stem cells, with the goal of expediting wound healing, promoting regenerative healing with minimal scarring, and halting wound progression. Further information regarding this phase 1/2a study (NCT05078385) can be found on clinicaltrials.gov.

Shelley Hartman, CEO of Aegle, expressed excitement over the launch of the AGLE-102 trial, underscoring its importance as a pioneering effort in the domain of extracellular therapy. She emphasized the potential of this comprehensive approach in addressing severe dermatological and immune-related conditions.

AGLE-102 is an experimental therapeutic formulation consisting of extracellular vesicles sourced from allogeneic stem cells. These vesicles encompass a mixture of cellular nanoparticles containing bioactive substances like proteins and nucleic acids, recognized for their properties related to tissue regeneration, immune modulation, and anti-inflammation. Aegle is presently enrolling participants for a phase 1/2a study to assess AGLE-102's ability to prevent wound progression and scarring in cases of severe second-degree burns. Moreover, plans are underway to launch a phase 1/2a study in Q4 2023 targeting the treatment of epidermolysis bullosa. Notably, AGLE-102 is also undergoing preclinical evaluation for the treatment of graft-versus-host disease (GvHD).

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