Astrocyte Pharmaceuticals is currently investigating several programs for the potential treatment of acute ischemic stroke, TBI, concussion, and other injuries to the brain.
The company’s lead program AST-004 is a novel small molecule candidate currently undergoing dose optimization, with confirmation of the clinical development candidate and initiation of regulatory preclinical toxicology studies in 2019.
Astrocyte Pharmaceuticals aims to begin human Phase I clinical safety trials for AST-004 in 2020, and human Phase II patient clinical efficacy trials in 2021. Subsequent Phase IIb and Phase III studies, and New Drug Application (NDA) review by regulatory agencies such as the FDA will typically take an additional 2-5 years to confirm results and approve use of the new therapeutic.
Follow-on programs for an oral or subcutaneous “field” formulation for mild TBI and concussions, and an oral chronic formulation for neurodegenerative diseases and migraine are being investigated.