At present, there are no proven neuroprotective pharmacological treatments for ICH or other forms of acute brain injuries. A novel therapeutic approach was developed based on the known biological function of endogenous apolipoprotein. In a Phase 1 trial evaluating the safety, tolerability, and pharmacokinetics of single escalating and repeated doses of the IP in healthy human adults, the compound was found to be safe and well tolerated, with no serious drug-related adverse events (AEs) reported.
The S-CATCH study evaluates the safety and potential efficacy of repeated doses of the investigational product administered to participants with acute supratentorial ICH.
SCRI supported the study as collaborator providing clinical operations support as well as scientific support. Clinical operation team supports project management, research monitoring, pharmacovigilance and data management. The biostatistician team from SCRI also led the development of CDISC compatible data for FDA submission.