Phase 1b study will evaluate small molecule adenosine receptor agonist for stroke, TBI

Key takeaways:

• AST-004 demonstrated promising cerebroprotective results in preclinical studies.
• A phase 1a study of the small molecule adenosine A₃/A₁ receptor agonist showed no significant adverse effects.

Astrocyte Pharmaceuticals Inc. announced initiation of a phase 1b study of AST-004, a small molecule adenosine A₃/A₁ receptor agonist for stroke and traumatic brain injuries that will be evaluated in healthy volunteers.

According to a release from Astrocyte, the study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AST-004 as a loading dose followed by continuous infusion over 6 hours. The results are expected to provide key data to support the company’s phase 2 plans for AST-004, which demonstrated promising cerebroprotective results in preclinical studies.

The new trial comes on the heels of a phase 1a study completed in 2022, in which single ascending 10-minute bolus doses of AST-004 showed no significant adverse effects or safety signals, the company stated.

“Astrocyte is committed to developing innovative therapies that treat brain injuries and improve the lives of patients,” Lisa Manna, MBA, Astrocyte’s vice president of clinical development operations, said in the release. “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.”

According to the release, the study — which will be conducted over the next 4 to 6 months at the QPS clinical research site in Groningen, Netherlands — will be funded in part by the Medical Technology Enterprise Consortium in cooperation with the U.S. Army Medical Research and Development Command of the U.S. Department of Defense.