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

April 5, 2023 |

4 min read

Astrocyte Pharmaceuticals Inc., 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.

GROTON, Conn.--(BUSINESS WIRE)-- Astrocyte Pharmaceuticals Inc., 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 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.

For more information on Astrocyte Pharmaceuticals and the AST-004 program, please visit www.astrocytepharma.com.

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 (MTEC) 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 (USAMRDC) 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. To find out more, visit https://mrdc.health.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.

Forward Looking Statement

This press release contains certain forward-looking statements regarding, among other things, statements relating to goals, plans and projections regarding the company’s financial position, results of operations, market position, product development and business strategy. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and the company undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.