Project Grant R44NS137896

This Project Grant award from the National Institute of Neurological Disorders and Stroke (NINDS), under the Extramural Research Programs in the Neurosciences and Neurological Disorders (CFDA 93.853) federal grant program, provides $1,499,886 to Astrocyte Pharmaceuticals Inc. to advance the development of an oral tablet formulation of the pharmaceutical agent AST-004 for the treatment of moderate traumatic brain injuries (TBI).

The key objectives of this 2-year project are to: (1) verify the efficacy of the oral AST-004 formulation in a large animal TBI model, and (2) conduct required preclinical toxicology studies. Successful completion of these activities will support an Investigational New Drug (IND) submission to the FDA and enable a subsequent Phase I clinical trial of the oral AST-004 tablet for moderate TBI patients. This work builds upon prior NINDS-funded research that demonstrated the efficacy of an intravenous formulation of AST-004 in a large animal TBI model, and advanced the drug candidate through Phase I human trials as an in-hospital treatment. Developing an oral tablet formulation is a critical step to enable further clinical evaluation and reach the broader population of mild-to-moderate TBI patients outside the hospital setting.