Astrocyte Announces Initiation of an Extended Infusion Phase 1B Study of AST-004 for Stroke and Traumatic Brain Injuries

Astrocyte Pharmaceuticals, a drug discovery and development company advancing novel cerebroprotective therapeutics for patients with brain injuries, is pleased to announce the initiation of a Phase 1B study of its lead candidate, AST-004, as an extended infusion in healthy volunteers. This adaptive-design clinical study will be conducted over the next four to six months at the QPS clinical research site in Groningen, Netherlands.

AST-004 is a small molecule adenosine A3/A1 receptor agonist that has consistently shown promising cerebroprotective results in preclinical studies. A Phase 1A study completed in 2022 with single ascending 10-minute bolus doses of AST-004 showed no significant adverse effects or safety signals. The Phase 1B study will assess the safety, tolerability, and pharmacokinetics and pharmacodynamics of AST-004 administered as a loading dose followed by a continuous infusion over 6 hours, and provide important data to support the company’s future Phase 2 program.

“Astrocyte is committed to developing innovative therapies that treat brain injuries and improve the lives of patients,” said Lisa Manna, Astrocyte’s Vice President of Clinical Development Operations. “The initiation of this Phase 1B study is an important step forward in the development of AST-004 supporting multiple indications, and we look forward to continuing the clinical development of this novel and promising therapy.”

The Astrocyte study 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.