NeuroScientific Biopharmaceuticals Limited (ASX:NSB), an innovative Australian biotechnology company developing novel technologies targeted at immune-mediated inflammatory diseases, has announced successful clinical results from its Special Access Program using StemSmart™ to treat patients with fistulising Crohn’s disease. According to the announcement, three out of four patients in Cohort 1 who were treated with NSB’s StemSmart™ MSC product experienced a successful Clinical Response. A fourth patient showed a partial response and is undergoing further assessments.
The company defines a Clinical Response as either closure of =50% of fistula openings or a decrease in fistula discharge of =50%, as assessed by the treating physician. NSB considers the successful Clinical Response in three patients and the partial response in the fourth to be significant validation for the StemSmart™ platform in a real-world setting. These results will directly inform the design of NSB’s planned later-phase clinical trials, scheduled to begin in the second half of 2026.
NSB Chief Executive Officer, Mr Nathan Smith, stated that the treatment results provide critical validation of the StemSmart™ MSC platform as a potential therapeutic solution for patients with debilitating fistulising Crohn’s disease. NSB Chief Medical Officer, Dr Cathy Cole, commented that the response rate to StemSmart™ MSC treatment seen in these patients is exceptional, given the serious and long-standing nature of their condition. These results set the foundation for entry into the ~$US13 billion Global Crohn’s disease market.
Currently, Phase 2 start-up activities are underway including the establishment of commercial manufacturing, clinical trial development and regulatory planning. The data generated through the Special Access Program will support the development of later phase clinical trials in fistulising Crohn’s Disease and a Phase 2 clinical trial in the broader indication of refractory Crohn’s disease.
