Aegle Therapeutics Corp., a pioneering company in the development of novel extracellular vesicle (EV) therapies, has recently announced the promising 12-week data for the first patient enrolled in a Phase 1/2a clinical trial of AGLE-102™ for treating severe second-degree burns.
This marks a significant milestone in the treatment of rare and severe dermatological conditions, including immuno-dermatological disorders.
Key Highlights of the Clinical Trial:
- Rapid Healing and Significant Improvement: The first patient treated with a single topical dose of AGLE-102 within 48 hours of the burn injury achieved 99% epithelialization of the burn wound and a significant reduction in edema within just seven days of treatment. This rapid healing process is a testament to the potential of AGLE-102 in revolutionizing burn treatment.
- No Further Treatment Required: Remarkably, subsequent doses of AGLE-102 were not required after the initial application, indicating the potent efficacy of the single dose in treating the burn wound.
- Safety and Efficacy: The patient showed no evidence of ischemia reperfusion injury, as measured by Laser Doppler, one week post-treatment, and no evidence of burn conversion was noted. The Patient and Observer Scar Assessment Scale (POSAS) measurements showed significant improvement seven days post-treatment and continued to improve over 12 weeks of follow-up. By day 90, the patient’s POSAS score improved from a score of 40 at baseline to a score of 10 (6 being normal), indicating minimal to no scarring. No safety issues were reported throughout the trial.
About AGLE-102™:
AGLE-102 is an investigational product comprised of extracellular vesicles isolated from allogeneic stem cells using Aegle’s proprietary and patented methods.
The product is a composite of native EVs and their associated complex assemblies of biologic molecules such as proteins, peptides, ligands, and nucleic acids.
These have the potential to induce a wide variety of effects in recipient cells, including reducing inflammation, modulating the immune system, and promoting regenerative healing.
About the Phase 1/2a Clinical Trial:
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 prospective, single-arm multi-center study designed to evaluate the safety and efficacy of applying AGLE-102 to deep second-degree burns. The program aims to discover and develop allogeneic stem cell-derived extracellular vesicle therapy that offers patients reduced inflammation, accelerated regenerative healing with minimal/no scarring, and prevention of burn conversion.
Future Prospects:
In addition to its phase 1/2a study in severe second-degree burns, Aegle’s pipeline includes an anticipated launch of a phase 1/2a study in Q1 2024 evaluating AGLE-102 for the treatment of the rare disease epidermolysis bullosa and a preclinical program for graft vs. host disease. Aegle’s EV therapy holds significant promise in treating a broad range of indications in multiple therapeutic areas in dermatology, including inflammatory disorders and immune-based conditions. The anti-inflammatory and immune modulatory effects of Aegle’s EV therapy also hold significant promise in the treatment of numerous other disorders in therapeutic areas outside of dermatology.
For more information about Aegle Therapeutics and their innovative work, please visit www.aegletherapeutics.com.