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 planned for the next 9-15 months.
Astrocyte Pharmaceuticals aims to begin human Phase I clinical trials for AST-004 in the next 1.5 -2.5 years, and demonstrate clinical proof of concept in a Phase II patient clinical trial by ~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 a sublingual “field” formulation for mild TBI and concussions, and an oral chronic formulation for neurodegenerative diseases and migraine are being investigated.