NeuroScientific Biopharmaceuticals secures US FDA meeting for StemSmart trials

Perth-based biotech company NeuroScientific Biopharmaceuticals has secured a Pre-Investigational New Drug (Pre-IND) meeting with the United States Food and Drug Administration (FDA), scheduled for August 31. This meeting is a critical regulatory step for the company as it prepares to advance its patented ‘StemSmart’ technology into Phase 2 clinical trials in the United States.

The StemSmart platform utilizes adult human donor bone marrow-sourced mesenchymal stem cells, manufactured through a patented process intended to enhance therapeutic activity and manage inflammatory immune responses. The company intends to target refractory Crohn’s disease, a severe and treatment-resistant form of inflammatory bowel disease, during these trials. NeuroScientific Biopharmaceuticals aims to submit its full IND application by the end of the calendar year.