Astcyte Pharmaceuticals Inc. is thrilled to announce the commencement of a Phase 1B study of its lead candidate, AST-004. This adaptive-design clinical study, to be conducted over the next four to six months at the QPS clinical research site in Groningen, Netherlands, will evaluate the safety and efficacy of AST-004 when administered as an extended infusion in healthy volunteers. The results will provide important data to support the development of novel cerebroprotective therapeutics for patients suffering from brain injuries.
In a Phase 1A study completed in 2022, AST-004, a small molecule adenosine A3/A1 receptor agonist, showed no significant adverse effects or safety signals when administered as a single ascending 10-minute bolus dose. Now, the company is moving forward with its Phase 1B study to further assess the safety, tolerability, and pharmacokinetics and pharmacodynamics of AST-004.
This study will involve a loading dose followed by a continuous infusion over 6 hours, and is an important step in the company’s plans to develop a Phase 2 program. Preclinical results have been consistently promising, demonstrating the potential of AST-004 as a cerebroprotective agent.
Astrocyte is dedicated to revolutionizing the treatment of brain injuries and improving the quality of life of patients through groundbreaking therapies. We are thrilled to take a major step forward in the development of AST-004 with the initiation of this Phase 1B study, which could potentially support a range of indications. We look forward to continuing the clinical development of this promising therapy.
The Medical Technology Enterprise Consortium (MTEC), in collaboration with the U.S. Army Medical Research and Development Command (USAMRDC) of the United States Department of Defense, is proud to announce its funding of a new and exciting study. This study has the potential to yield exciting advancements in medical technology, and we are excited to see what discoveries may come of it.
About Astrocyte Pharmaceuticals Inc.
Astrocyte Pharmaceuticals Inc. is an innovative, clinical-stage drug discovery and development company with a mission to improve the lives of individuals with brain injury. By harnessing the power of astrocyte function, the company is passionately working to develop therapeutic agents that provide cerebroprotective benefits to those impacted by stroke, traumatic brain injury, concussion, and neurodegenerative diseases such as Alzheimer’s. Astrocyte Pharmaceuticals is on a mission to accelerate the recovery and well-being of brain injury patients.
The Medical Technology Enterprise Consortium (MTEC) is a groundbreaking biomedical technology consortium that is making waves in the medical research and development space. Through a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Development Command, MTEC is dedicated to developing solutions that protect, treat, and optimize the health and performance of U.S. military personnel and civilians. With a global reach and a passion for innovation, MTEC is revolutionizing the way we think about medical technology.
About U.S. Army Medical Research and Development Command
The U.S. Army Medical Research and Development Command (USAMRDC) is the Army’s premier biomedical research organization, committed to providing life-saving medical solutions for the battlefield.
Focusing on a range of areas, including military infectious diseases, combat casualty care, military operational medicine, and medical chemical and biological defense, USAMRDC strives to ensure that the brave men and women of the armed forces have access to the best possible medical care.
The opinions expressed in this article are my own and may not necessarily reflect the official stance of the Department of the Army, Department of Defense, or the U.S. government. Nevertheless, I hope that my perspective provides an interesting and thought-provoking look into the topic at hand.