Pharma Focus Europe

Aegle Therapeutics Corp. Shares Positive Outcomes for the First Participant in Phase 1/2a Clinical Trial Treated with AGLE-102™, a Novel Extracellular Vesicle Therapy

Tuesday, January 09, 2024

Aegle Therapeutics Corp. has revealed positive results from the initial 12-week evaluation of the first participant in its Phase 1/2a clinical trial for AGLE-102™, an innovative extracellular vesicle ("EV") therapy designed for severe second-degree burns. The patient, who received a single topical dose of AGLE-102 within 48 hours of sustaining the burn injury, showed a remarkable 99% epithelialization of the burn wound and experienced a substantial reduction in edema within seven days of treatment. Notably, additional doses of AGLE-102 were not deemed necessary.

The patient exhibited no signs of ischemia reperfusion injury one week post-treatment, as assessed by Laser Doppler, and there was no evidence of burn conversion. Assessments using the Patient and Observer Scar Assessment Scale (POSAS) demonstrated significant improvement within seven days of treatment, persisting over the 12-week follow-up period. By day 90, the patient's POSAS score, measuring pain, itch, thickness, stiffness, color, and irregularity, improved from a baseline score of 40 to an impressive score of 10 (with 6 considered normal). Importantly, no safety concerns were reported.

Shelley Hartman, Aegle's Chief Executive Officer, expressed satisfaction with the promising results from the inaugural participant in the AGLE-102 trial, emphasizing the company's dedication to advancing EV therapy as an innovative and comprehensive approach to addressing rare and severe dermatological conditions.

AGLE-102™ is an experimental product comprising extracellular vesicles derived from allogeneic stem cells utilizing Aegle's proprietary methods. This product consists of native EVs and their associated complex assemblies of biologic molecules, including proteins, peptides, ligands, and nucleic acids. These components hold the potential to elicit various effects in recipient cells, such as reducing inflammation, modulating the immune system, and promoting regenerative healing.

The Phase 1/2a clinical trial, titled "A Pilot Safety Study of Mesenchymal Stem Cell Derived Extracellular Vesicles for the Treatment of Burn Wounds," is a prospective, single-arm, multi-center study designed to assess the safety and efficacy of applying AGLE-102 to deep second-degree burns. This program aims to discover and develop allogeneic stem cell-derived extracellular vesicle therapy, offering reduced inflammation, accelerated regenerative healing with minimal or no scarring, and prevention of burn conversion for patients. Additional details about the Phase 1/2a study (NCT05078385) are available on



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