AGLE-102 is a novel extracellular vesicle therapy being developed for the treatment of rare and immuno-dermatological disorders.
WOBURN, MA, USA I August 14, 2024 I Aegle Therapeutics Corp., a clinical-stage biopharmaceutical company developing novel extracellular vesicle (“EV”) therapies to address immune and inflammatory-based dermatological disorders, today announced that the first patient has been dosed in a Phase 1/2a clinical study evaluating AGLE-102™ for the treatment of the rare pediatric skin blistering disease DEB.
AGLE-102 is an investigational product comprised of extracellular vesicles isolated from allogeneic stem cells using Aegle’s proprietary methods. AGLE-102 is a native composite of cell-derived nanoparticles that contain active biomolecules including proteins and nucleic acids with anti-inflammatory, immunomodulating, and tissue regenerating properties.
“We are thrilled to announce the initiation of this Phase 1/2a clinical trial for DEB, a complex disease characterized by chronic blistering and excessive inflammation. Aegle is committed to advancing new therapies to address the continued unmet medical need of this patient population,” said Shelley Hartman, Aegle’s Chief Executive Officer.
Evangelos Badiavas, MD, PhD, Co-Founder and Chief Scientific Officer, said “AGLE-102 is designed to mimic the body’s healing mechanism by delivering proteins, including collagen 7, and other important biomolecules such as nucleic acids that act by reducing inflammation, modulating the immune system and inducing diseased cells to make their own collagen 7. AGLE-102 offers a unique, multifaceted approach to the treatment of DEB.”
The phase I/2a trial, “A Safety Study of the Administration of Mesenchymal Stem Cell Extracellular Vesicles in the Treatment of Dystrophic Epidermolysis Bullosa Wounds”, is a prospective, non-randomized, multi-center study designed to evaluate the safety and efficacy of multiple doses of AGLE-102 in the treatment of chronic lesions. More information on the study (NCT04173650) is available at clinicaltrials.gov.
About AGLE-102™
AGLE-102 is a native composite of nanoparticles called extracellular vesicles that are released by allogeneic mesenchymal stem cells. These EVs carry complex assemblies of active biomolecules that can induce a wide variety of effects in recipient cells. AGLE-102 is being evaluated in two phase 1/2a studies in DEB and severe burns. Compelling clinical results have been previously reported in burns (https://www.prnewswire.aegle-therapeutics-302027568.html). AGLE-102 is also in a preclinical program for GvHD.
About Aegle Therapeutics Corp.
Aegle Therapeutics is a clinical-stage biopharmaceutical company developing novel extracellular vesicle therapies for the treatment of immune and inflammatory-based dermatological disorders. For more information visit www.aegletherapeutics.com.
SOURCE: Aegle Therapeutics
Post Views: 5,138
AGLE-102 is a novel extracellular vesicle therapy being developed for the treatment of rare and immuno-dermatological disorders.
WOBURN, MA, USA I August 14, 2024 I Aegle Therapeutics Corp., a clinical-stage biopharmaceutical company developing novel extracellular vesicle (“EV”) therapies to address immune and inflammatory-based dermatological disorders, today announced that the first patient has been dosed in a Phase 1/2a clinical study evaluating AGLE-102™ for the treatment of the rare pediatric skin blistering disease DEB.
AGLE-102 is an investigational product comprised of extracellular vesicles isolated from allogeneic stem cells using Aegle’s proprietary methods. AGLE-102 is a native composite of cell-derived nanoparticles that contain active biomolecules including proteins and nucleic acids with anti-inflammatory, immunomodulating, and tissue regenerating properties.
“We are thrilled to announce the initiation of this Phase 1/2a clinical trial for DEB, a complex disease characterized by chronic blistering and excessive inflammation. Aegle is committed to advancing new therapies to address the continued unmet medical need of this patient population,” said Shelley Hartman, Aegle’s Chief Executive Officer.
Evangelos Badiavas, MD, PhD, Co-Founder and Chief Scientific Officer, said “AGLE-102 is designed to mimic the body’s healing mechanism by delivering proteins, including collagen 7, and other important biomolecules such as nucleic acids that act by reducing inflammation, modulating the immune system and inducing diseased cells to make their own collagen 7. AGLE-102 offers a unique, multifaceted approach to the treatment of DEB.”
The phase I/2a trial, “A Safety Study of the Administration of Mesenchymal Stem Cell Extracellular Vesicles in the Treatment of Dystrophic Epidermolysis Bullosa Wounds”, is a prospective, non-randomized, multi-center study designed to evaluate the safety and efficacy of multiple doses of AGLE-102 in the treatment of chronic lesions. More information on the study (NCT04173650) is available at clinicaltrials.gov.
About AGLE-102™
AGLE-102 is a native composite of nanoparticles called extracellular vesicles that are released by allogeneic mesenchymal stem cells. These EVs carry complex assemblies of active biomolecules that can induce a wide variety of effects in recipient cells. AGLE-102 is being evaluated in two phase 1/2a studies in DEB and severe burns. Compelling clinical results have been previously reported in burns (https://www.prnewswire.aegle-therapeutics-302027568.html). AGLE-102 is also in a preclinical program for GvHD.
About Aegle Therapeutics Corp.
Aegle Therapeutics is a clinical-stage biopharmaceutical company developing novel extracellular vesicle therapies for the treatment of immune and inflammatory-based dermatological disorders. For more information visit www.aegletherapeutics.com.
SOURCE: Aegle Therapeutics
Post Views: 5,138
