Aegle Therapeutics Corp. Announces Positive Data for the First Patient in a Phase 1/2a Clinical Trial Dosed With AGLE-102™, a Novel Extracellular Vesicle Therapy

2024-01-08

临床结果临床研究细胞疗法

[08-January-2024] First patient treated with AGLE-102 demonstrated 99% epithelialization in a deep second-degree burn within 7 days of receiving a single dose No evidence of burn wound conversion nor ischemia reperfusion injury as evidenced clinically and by laser doppler studies WOBURN, Mass. and MIAMI, Jan. 8, 2024 /PRNewswire/ -- Aegle Therapeutics Corp., a leader in the development of novel extracellular vesicle ("EV") therapies to treat rare and severe dermatological, including immuno-dermatological, conditions, today announced positive 12-week data for the first patient enrolled in a Phase 1/2a clinical trial of AGLE-102™ for the treatment of severe second-degree burns. The first patient was treated with a single topical dose of AGLE-102 within 48 hours of burn injury. The patient achieved 99% epithelialization of the burn wound and had a significant reduction in edema within seven days of treatment. Subsequent doses of AGLE-102 were not required. The patient had no evidence of ischemia reperfusion injury, as measured by Laser Doppler, one week post treatment, and no evidence of burn conversion was noted. 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 (which measures pain, itch, thickness, stiffness, color and irregularity) improved from a score of 40 at baseline to a score of 10 (6 being normal). No safety issues were reported. "We are very pleased with the first patient's results in this first-in-human trial of AGLE-102," said Shelley Hartman, Aegle's Chief Executive Officer. "This milestone highlights our commitment to advancing EV therapy as an important, novel, multi-faceted approach to treating rare and severe dermatological conditions." About AGLE-102TM 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 that 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 I/2a trial, "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 is being advanced for the discovery and development of allogeneic stem cell derived extracellular vesicle therapy that has the potential to offer patients reduced inflammation, accelerated regenerative healing (with minimal/no scarring) and prevention of burn conversion. More information on the phase 1/2a study (NCT05078385) is available at clinicaltrials.gov. About Aegle Therapeutics Corp. Aegle Therapeutics is a clinical-stage regenerative medicine biotechnology company developing novel EV therapies to treat rare and serious dermatological, including immuno-dermatological, disorders with significant unmet medical need. Aegle's proprietary platform technology safely isolates a broad composite of native EVs from stem cells. 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 has the potential to treat a broad range of indications in multiple therapeutic areas in dermatology including inflammatory disorders, immune-based conditions and others. 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, please visit . For More Information Contact: info@aegletherapeutics.com