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.

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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Thermo Scientific™ Dionex™ Inuvion™ Ion Chromatography (IC) system, helping to make ion analysis simpler and more intuitive for labs of all sizes. The new analytical instrument is designed to be easily reconfigurable, providing those who require determination of ionic and small polar compounds with a one stop shop for consistent, reliable ion analysis.
This new collaboration is another example of Blacksmith's creative deal-making with top tier partners that bring expertise to the table which helps de-risk and accelerate scientific discoveries for the development of valuable products.
Heparin Sodium 2,000 units in 0.9% Sodium Chloride Injection 1,000 mL (2 units/mL), is indicated as an anticoagulant to maintain catheter patency.
Through this agreement, RaySearch acquires full ownership of all rights to the product DrugLog for its application in the field of oncology, including the measuring device, calibration parameters, source code, as well as intellectual property rights.
Anna Kazanchyan, MD, Founder and CEO of Saghmos Therapeutics. "We are very pleased to announce the Notice of Allowance for our second patent, which will enhance the long-term value of ST-62516. Saghmos continues to build its intellectual property estate."

By using this website you agree to accept Medical Device News Magazine Privacy Policy