NeuroScientific Biopharmaceuticals (ASX:NSB) Gains TGA Approval for First Patients in Special Access Program for StemSmart(TM) Crohn's Disease Therapy
Jane Morgan Management
7 October 2025 – Perth, Australia | NeuroScientific Biopharmaceuticals Limited (ASX:NSB) has today announced that the first three patients have been approved for treatment under the Therapeutic Goods Administration (TGA)’s Special Access Program to receive its patented stem cell therapy, StemSmart™, to treat fistulising Crohn’s disease.
The patients are now part of Cohort 1 for the Company’s Special Access Program, which was launched following the Company’s acquisition of Isopogen WA Ltd and its proprietary StemSmart™ patented stem cell technology. Approval under Category B of the Special Access Scheme in Australia is required for using unapproved therapies, and signifies a major milestone for the Company’s clinical development program as it progresses towards a Phase 2 trial that is targeted for 2026.
Chief Executive Officer, Mr Nathan Smith, stated: “I am extremely excited with the TGA approval to treat patients with StemSmart™ as we advance the Special Access Program towards completion by mid-2026. This milestone, alongside our progress in transferring the manufacturing technology to Q-Gen in parallel, paves the way towards initiation of our Phase 2 clinical trial next year.”
StemSmart™ is a mesenchymal stem cell (MSC) therapy that is derived from donated adult human bone marrow. The Company’s proprietary manufacturing process is designed to enhance the clinical efficacy of MSCs. Previous studies have demonstrated strong safety and early efficacy signals in severe and treatment-resistant Crohn’s disease, which is a key unmet clinical need.
The Special Access Program targets fistulising Crohn’s disease, one of the most debilitating complications of inflammatory bowel disease. Patients approved under the Special Access Program are those with limited or no treatment options that are demonstrating efficacy for them, and the Company expects outcomes to directly support regulatory pathways for a full Phase 2 trial in refractory Crohn’s disease.
The global market opportunity for StemSmart™ is significant, with the Crohn’s disease therapeutic market being forecasted to reach approximately US$13.8 billion by 2026. Additional potential applications for the StemSmart™ technology include kidney transplant immunosuppression, lung disorders, and graft-versus-host disease (GvHD).
For further information please contact:
Nathan Smith
Chief Executive Officer
[email protected]
Jane Morgan
Investor & Media Relations
Jane Morgan Management
[email protected]
About us:
About NeuroScientific Biopharmaceuticals Ltd
NeuroScientific Biopharmaceuticals Limited (ASX:NSB) is a biotechnology company focused on the development of novel therapeutics targeting immune-mediated inflammatory disorders. The Company’s research is centred on modulating pathological immune responses involved in chronic and degenerative conditions, particularly where current therapeutic options demonstrate limited efficacy or durability. NSB applies advanced preclinical and translational strategies to support the development of first-in-class or best-in-class biologics addressing significant unmet clinical need.
Contact details:
Jane Morgan
Investor & Media Relations
Jane Morgan Management
[email protected]