NeuroScientific Biopharmaceuticals (ASX:NSB) has announced encouraging results from its Special Access Program for patients with fistulising Crohn's disease.
Of the four patients treated in Cohort 1 with the company's StemSmart mesenchymal stem cell therapy, three achieved a full clinical response, while the fourth demonstrated a partial response with ongoing assessments.
Clinical response was defined as at least a 50% reduction in fistula openings or discharge, as determined by the treating physician.
The treatments, approved under the Therapeutic Goods Administration Category B pathway, address critical unmet medical needs for patients with limited therapeutic options.
NSB CEO Nathan Smith described the results as "critical validation" of the StemSmart platform, emphasising their significance in informing upcoming Phase 2 trials scheduled to begin in the second half of 2026.
The therapy, derived from adult human donor bone marrow MSCs, is positioned as a versatile cell therapy with broader potential in immune-mediated inflammatory conditions, including organ transplant immune tolerance, lung inflammatory disease, and graft-versus-host disease.
NSB aims to advance clinical development and commercialisation in a global market projected to reach over US$13 billion for Crohn's disease alone.