Astrocyte Announces Initiation of First-In-Human Phase 1 Study of the Promising Stroke and Traumatic Brain Injury Therapeutic, AST-004

Groton, CT, June15,2022–Astrocyte Pharmaceuticals Inc.,a drug discovery and development company advancingnovel cerebroprotective therapeutics for patients with brain injuries, announced that the Company’s first-in-humanPhase 1 clinical study initiatedtoday with the dosing of a first subject withAST-004. The promising investigationaltherapeutic,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 levelsover the next sixmonths 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. 

OnceAST-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.”