13 January 2026 – Perth, Australia | NeuroScientific Biopharmaceuticals Limited (ASX:NSB) has today announced a “Clinical Response” from patients treated with its patented StemSmart™ Mesenchymal Stem Cell (MSC) therapy under the Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS) for fistulising Crohn’s disease.
Three of four patients treated in Cohort 1 of the Special Access Program demonstrated a successful “Clinical Response” following treatment with StemSmart™, with the fourth patient showing a partial response with further clinical assessment needed.
A Clinical Response is defined as either closure of at least 50 per cent of fistula openings or a reduction in fistula discharge of at least 50 per cent, as assessed by the treating physician or qualified investigator.
The Company said the results are significant given the severity of fistulising Crohn’s disease and the limited treatment options available to these patients, which is often resistant to currently approved therapies. All patients in the Program were approved for treatment under the SAS Category B pathway, which allows access to unapproved therapies for patients with serious and life-threatening conditions where conventional treatments are ineffective or unavailable.
NeuroScientific Chief Executive Officer Mr Nathan Smith said the outcomes provide important validation of the StemSmart™ platform in a real-world clinical setting.
“These treatment results provide critical validation of the StemSmart™ MSC platform in presenting a potential therapeutic solution to patients with debilitating fistulising Crohn’s disease that have limited effective treatment options.
This data, along with our previous clinical trial results in refractory Crohn’s disease, provides a strong foundation for our commercialisation plans for StemSmart™ moving forward.
Together, these early outcomes allow us to advance the development of a novel therapeutic in a responsible, informed, and patient-centred fashion as it supports and accelerates our progress toward clinical trial work later this year.”
Chief Medical Officer Dr Cathy Cole said the response rates observed were notable given the advanced nature of the patients’ disease.
“The response rate to StemSmart™ MSC treatment seen in these patients in a real-world setting is exceptional, given the serious, debilitating and long-standing adverse nature of their condition. If you consider that for these fistula patients treated with StemSmart™, there were limited treatment options available, then the response to treatment is truly outstanding and offers hope for clinical recovery when there was previously little.”
The StemSmart™ MSC therapeutic is derived from adult human donor bone marrow-sourced MSCs and is produced using a patented manufacturing process designed to enhance their therapeutic effect. Early indications from a previous Phase 2 trial in refractory Crohn’s disease suggested the therapy was potent, efficacious and safe.
NeuroScientific said data generated through the Special Access Program will directly inform the design of its planned later-phase clinical trials, which are expected to commence in the second half of 2026. Phase 2 start-up activities are already underway, including commercial manufacturing scale-up, clinical trial development and regulatory planning.
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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.
Targeting Crohn’s Disease with StemSmart™ Technology
Following the acquisition of Isopogen WA Ltd, NSB is prioritizing the application of its proprietary StemSmart technology through a SAS program targeting fistulising Crohn’s disease—a severe and treatment-resistant form of the condition. Favourable outcomes will support the Company’s progression to a Phase 2 clinical trial to further evaluate safety and preliminary efficacy in refractory and/or fistulising Crohn’s disease. This initiative aligns with NSB’s broader strategy to obtain regulatory and reimbursement approval for its MSC therapy both in Australia and internationally, with the goal of making the treatment available to patients with fistulising and refractory Crohn’s disease, for whom current therapies remain inadequate.
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