GROTON, CT, USA I June 15, 2022 I Astrocyte Pharmaceuticals Inc., a drug discovery and development company advancing novel cerebroprotective therapeutics for patients with brain injuries, announced that the Company’s first-in-human Phase 1 clinical study initiated today with the dosing of a first subject with AST-004. The promising investigational therapeutic, AST-004, is being advanced as a potential acute treatment for stroke and traumatic brain injury (TBI) victims, and as a chronic treatment for neurodegenerative diseases like Alzheimer’s. AST-004 has demonstrated a broad range of cerebroprotective efficacy when treating preclinical animal models, including preserving up to 45 percent more brain tissue in a non-human primate model of stroke, beyond that of reperfusion standard of care (study published in Stroke).
The primary objective of the first-in-human study, designated AST-004-1-02, is to evaluate the safety, tolerability and pharmacokinetic profile of AST-004 in healthy normal human subjects. The study will include up to 52 healthy participants aged 18 to 55 years and is funded in part by the Medical Technology Enterprise Consortium (MTEC) in cooperation with the U.S. Army Medical Research and Development Command (USAMRDC) of the United States of America Department of Defense.
“AST-004 demonstrated significant safety in the required regulatory animal studies, and we look forward to taking this next step of understanding its safety and pharmacokinetics in humans,” explained Lisa Manna, Vice President of Clinical Development Operations at Astrocyte. “The study will assess AST-004 at multiple dose levels over the next six months at the clinical research site in Kistarcsa, near Budapest, Hungary.”
“Initiating clinical studies is a major milestone as it reflects the many multi-disciplinary components of drug development such as preclinical pharmacology, efficacy, safety, pharmacokinetics, manufacturing, etc., have all been addressed to the satisfaction of regulatory authorities,” said William Korinek, PhD, Chief Executive Officer, Astrocyte Pharmaceuticals.
Once AST-004 proves to be tolerated and have a favorable safety profile in the study, Astrocyte will progress to Phase 2 studies to evaluate its efficacy as a potential treatment approach for stroke and TBI patients. Dr. Korinek continued, “The AST-004 program continues its steady advancement, and we all look forward to additional data to understand its potential as a much needed treatment for the millions of people suffering from brain injuries.”
About Astrocyte Pharmaceuticals Inc.
Astrocyte Pharmaceuticals Inc. is a privately held, clinical stage, drug discovery and development company dedicated to accelerating the recovery and well-being of brain injury patients. The company is committed to proving the cerebroprotective benefits of enhancing astrocyte function, and advancing breakthrough therapeutic agents for treating brain injury resulting from stroke, traumatic brain injury, concussion, and neurodegenerative disorders such as Alzheimer’s disease. For more information, please visit us at Astrocyte Pharmaceuticals Inc.
About MTEC
The Medical Technology Enterprise Consortium is a biomedical technology consortium that is internationally-dispersed, collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Development Command. The consortium focuses on the development of medical solutions that protect, treat, and optimize the health and performance of U.S. military personnel and civilians. To find out more about MTEC, visit mtec-sc.org.
About U.S. Army Medical Research and Development Command
The U.S. Army Medical Research and Development Command is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical and biological defense. https://mrdc.amedd.army.mil/
The views expressed in this article are those of the author and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. government.
SOURCE: Astrocyte
Post Views: 37
GROTON, CT, USA I June 15, 2022 I Astrocyte Pharmaceuticals Inc., a drug discovery and development company advancing novel cerebroprotective therapeutics for patients with brain injuries, announced that the Company’s first-in-human Phase 1 clinical study initiated today with the dosing of a first subject with AST-004. The promising investigational therapeutic, AST-004, is being advanced as a potential acute treatment for stroke and traumatic brain injury (TBI) victims, and as a chronic treatment for neurodegenerative diseases like Alzheimer’s. AST-004 has demonstrated a broad range of cerebroprotective efficacy when treating preclinical animal models, including preserving up to 45 percent more brain tissue in a non-human primate model of stroke, beyond that of reperfusion standard of care (study published in Stroke).
The primary objective of the first-in-human study, designated AST-004-1-02, is to evaluate the safety, tolerability and pharmacokinetic profile of AST-004 in healthy normal human subjects. The study will include up to 52 healthy participants aged 18 to 55 years and is funded in part by the Medical Technology Enterprise Consortium (MTEC) in cooperation with the U.S. Army Medical Research and Development Command (USAMRDC) of the United States of America Department of Defense.
“AST-004 demonstrated significant safety in the required regulatory animal studies, and we look forward to taking this next step of understanding its safety and pharmacokinetics in humans,” explained Lisa Manna, Vice President of Clinical Development Operations at Astrocyte. “The study will assess AST-004 at multiple dose levels over the next six months at the clinical research site in Kistarcsa, near Budapest, Hungary.”
“Initiating clinical studies is a major milestone as it reflects the many multi-disciplinary components of drug development such as preclinical pharmacology, efficacy, safety, pharmacokinetics, manufacturing, etc., have all been addressed to the satisfaction of regulatory authorities,” said William Korinek, PhD, Chief Executive Officer, Astrocyte Pharmaceuticals.
Once AST-004 proves to be tolerated and have a favorable safety profile in the study, Astrocyte will progress to Phase 2 studies to evaluate its efficacy as a potential treatment approach for stroke and TBI patients. Dr. Korinek continued, “The AST-004 program continues its steady advancement, and we all look forward to additional data to understand its potential as a much needed treatment for the millions of people suffering from brain injuries.”
About Astrocyte Pharmaceuticals Inc.
Astrocyte Pharmaceuticals Inc. is a privately held, clinical stage, drug discovery and development company dedicated to accelerating the recovery and well-being of brain injury patients. The company is committed to proving the cerebroprotective benefits of enhancing astrocyte function, and advancing breakthrough therapeutic agents for treating brain injury resulting from stroke, traumatic brain injury, concussion, and neurodegenerative disorders such as Alzheimer’s disease. For more information, please visit us at Astrocyte Pharmaceuticals Inc.
About MTEC
The Medical Technology Enterprise Consortium is a biomedical technology consortium that is internationally-dispersed, collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Development Command. The consortium focuses on the development of medical solutions that protect, treat, and optimize the health and performance of U.S. military personnel and civilians. To find out more about MTEC, visit mtec-sc.org.
About U.S. Army Medical Research and Development Command
The U.S. Army Medical Research and Development Command is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical and biological defense. https://mrdc.amedd.army.mil/
The views expressed in this article are those of the author and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. government.
SOURCE: Astrocyte
Post Views: 37
