Therapy Areas: Infectious Diseases
Astrocyte Initiates First-In-Human Phase 1 Study of the Promising Stroke and Traumatic Brain Injury Therapeutic, AST-004
15 June 2022 - - US-based drug discovery and development company Astrocyte Pharmaceuticals Inc's first-in-human Phase 1 clinical study initiated TODAY with the dosing of a first subject with AST-004, the company said.

The promising investigational therapeutic, AST-004, is being advanced as a potential acute treatment for stroke and traumatic brain injury 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% 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 in cooperation with the US Army Medical Research and Development Command (USAMRDC) of the United States of America Department of Defense.

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.

Astrocyte Pharmaceuticals 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.

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 US 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 US military personnel and civilians.

The US 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. 
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